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Senior Director, Regulatory Affairs CMC

🔖 Full Time

📑 Senior Director, Regulatory Affairs CMCHybrid - Philadelphia, PAMeet has partnered with a very well-established pharma with hundreds of approved products. They are looking for a Senior Director of Regulatory CMC (small molecule) to join their team. This position will be working across the compan ...

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Senior Manager/Associate Director, Regulatory Affairs CMC

🔖 Full Time

📑 Role Title: Senior Manager/Associate Director, Regulatory Affairs CMCDepartment: Regulatory AffairsFLSA ExemptCORE VALUES Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration<str ...

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Senior Director Regulatory Affairs

🔖 Full Time

📑 Senior Director, Regulatory Affairs (Generalist)Hybrid Role - 3 Days in Menlo Park, CAMeet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory ...

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Director, CMC Regulatory Affairs

🔖 Full Time

📑 Director, CMC Regulatory AffairsDirect Hire Fulltime RoleSalary Range: $208,000 - $235,000 per yearLocation: Redwood City, CA - Hybrid RoleJob Summary:The position is responsible for providing CMC regulatory strategies and lead ...

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Director, CMC Regulatory Affairs

🔖 Full Time

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Sr. Dir/Director of Regulatory CMC

🔖 Full Time

📑 Remote - Candidates must be located in the United States - Ideally Southern California The Sr. Director/Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of BLA submissi ...

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Director, Regulatory CMC

🏢 Editas Medicine
📌 Cambridge, Massachusetts, , United States
💼 other general
⌚ 0 hours ago

🔖 Full Time

📑 At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We ...

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Regulatory Affairs CMC Animal Heath

🔖 Full Time

📑 Responsibilities: We are inviting applications for the role of CMC Regulatory affairs. Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis and assessment for Annex comparative table with reference EU Member States Manage execution / authoring and review of CMC docume ...

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Director, Regulatory Affairs, Oncology - Job ID: 1311

🏢 Ascendis Pharma
📌 Palo Alto, California, , United States
💼 other general
⌚ 0 hours ago

🔖 Full Time

📑 The Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants. May mentor and potentially supervise ot ...

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Senior Director, GRA Pharmaceuticals - Small Molecule

🔖 Full Time

📑 At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.<p ...

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Director, Regulatory Affairs Vaccines CMC

🏢 Takeda
📌 Boston, MA, United States
💼 other general
⌚ 23 hours ago

🔖 Full Time

📑 About the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to pat ...

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Senior Director Regulatory Affairs

🔖 Full Time

📑 Senior Director, Regulatory AffairsSan Francisco, CA (Hybrid)Join this Bioscience company on the forefront of groundbreaking therapeutics! I'm supporting a company seeking a dynamic individual for the role of Sr. Director, Regulatory Affairs. This pivotal position offers the opp ...

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Associate Director, Formulation and Drug Delivery

🏢 Astrix
📌 South San Francisco, CA, United States
💼 other general
⌚ 23 hours ago

🔖 Full Time

📑 Our client is a clinical stage biopharmaceutical company dedicated to improving patients’ lives. They develop multiple precision medicines targeting hallmark cancer resistance mechanisms.Title: Associate Director, Formulation and Drug DeliveryLocation: South San Francisco, California </p ...

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Regulatory Affairs Manager

🔖 Full Time

📑 Regulatory Affairs ManagerReporting Reports to VP, Quality Assurance and Regulatory AffairsCompany Akston Biosciences is inventing, developing, and manufacturing breakthrough protein therapeutics for Companion Animal Health. Our integrated capabilities, from d ...

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Manager, Regulatory Affairs: Job ID- 1322

🏢 Ascendis Pharma
📌 Palo Alto, California, , United States
💼 management
⌚ 0 hours ago

🔖 Full Time

📑 Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology. ...

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Associate Regulatory Affairs-CMC

🏢 Aequor Technologies LLC
📌 Thousand Oaks, California, , United States
💼 other general
⌚ 0 hours ago

🔖 Full Time

📑 FULLY REMOTE The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing and executing on regulatory ...

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Associate Regulatory Affairs-CMC

🏢 Donatech Corporation
📌 Thousand Oaks, California, , United States
💼 other general
⌚ 4 days ago

🔖 Full Time

📑 Position would require the candidate to be a W2 employee of DonatechUS Citizenship/Permanent Resident RequiredFULLY REMOTEThe Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufactu ...

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CMC Regulatory Affairs Manager

🏢 Katalyst Healthcares &amp; Life Sciences
📌 Tarrytown, New York, , United States
💼 management
⌚ 4 days ago

🔖 Full Time

📑 Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable regulations and guidelines. Provide regulatory guid ...

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Director CMC - Drug Substance Development and Manufacturing

🔖 Full Time

📑 The CMC Director of Drug Substance Development and Manufacturing is primarily responsible for the development and manufacturing of small molecule drug substances in support of clinical development and commercialization of Neurocentria’s pipeline compounds. The individual will provide technical and organizational leadership and w ...

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Marketing/Communications - 3D Digital Designer II 3D Digital Designer II

🏢 Softpath System LLC
📌 Short Hills, New Jersey, , United States
💼 sales and related
⌚ 0 hours ago

🔖 Full Time

📑 Job Description: We are inviting applications for the role of CMC 2 Regulatory affairs. Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States Manage execution / authoring and review of CMC documentation ...

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Director, GRA CMC Pharmaceuticals, Oligonucleotides

🔖 Full Time

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Global Regulatory CMC Manager

🏢 TechDigital Corporation
📌 Lawrenceville, New Jersey, , United States
💼 management
⌚ 10 days ago

🔖 Full Time

📑 BS/BA degree in Scientific Discipline with3 years in the pharmaceutical industry, preferably with 1 year CMC regulatory experienceResponsibilities will include, but are not limited to, the following:1. Participate in the development of the CMC regulatory strategy for biologics submissions. ...

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Global Regulatory CMC Manager

🏢 Katalyst Healthcares &amp; Life Sciences
📌 Lawrenceville, New Jersey, , United States
💼 management
⌚ 6 days ago

🔖 Full Time

📑 Responsibilities: Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision. Responsible for the global regulatory evaluation of CMC ch ...

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CMC Regulatory Affairs Specialist

🔖 Full Time

📑 Job title: CMC Regulatory Technical Writer II Location: Bridgewater, NJ, Hybrid Duration: 1 year SHIFT SCHEDULE 1st shift, 9-5 EST Mon-Fri Pay Rate starts: $47/ HOUR HM Notes: Hybrid ...

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Marketing/Communications - 3D Digital Designer II

🏢 Varite, Inc
📌 Short Hills, New Jersey, , United States
💼 sales and related
⌚ 0 hours ago

🔖 Full Time

📑 Pay rate range:$35-40/hr.Job Description:We are inviting applications for the role of CMC 2 Regulatory affairs.Responsibilities:• Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Membe ...

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Global Regulatory CMC Manager

🏢 Katalyst Healthcares &amp; Life Sciences
📌 Summit, New Jersey, , United States
💼 management
⌚ 0 hours ago

🔖 Full Time

📑 Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings. Prepare and review CMC submission documents, regist ...

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Scientific - Global Regulatory CMC Manager

🔖 Full Time

📑 PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience. Experience with sterile products preferred.Location can be Lawrenceville or Summit West.Responsibilities wil ...

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Lead for Global Regulatory Affairs, Plasma

🔖 Full Time

📑 CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspi ...

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CMC Senior Manager

🏢 Sunrise Systems Inc
📌 New Brunswick, New Jersey, , United States
💼 management
⌚ 0 hours ago

🔖 Full Time

📑 Job Title: CMC Senior ManagerJob ID: (phone number removed)Location: New Brunswick, NJDuration: 06 Months contract on W2 PREREQUISITES BS/BA degree in Scientific Discipline (master's or higher preferred) with ...

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Associate Director Regulatory Affairs

🔖 Full Time

📑 The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriad’s gene therapy product development, registration, and post-approval strategies. The position will be responsible for crafting and assuring development and execution of regulator ...

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Associate Regulatory Affairs

🏢 Aditi Consulting
📌 Thousand Oaks, California, , United States
💼 other general
⌚ 2 days ago

🔖 Full Time

📑 Summary:The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing and executing on regulatory CMC pro ...

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Regulatory Affairs Specialist

🏢 Katalyst Healthcares &amp; Life Sciences
📌 Short Hills, New Jersey, , United States
💼 other general
⌚ 0 hours ago

🔖 Full Time

📑 Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers Experience in reviewing of quality documents su ...

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Regulatory Affairs Specialist

🏢 Katalyst Healthcares &amp; Life Sciences
📌 Short Hills, New Jersey, , United States
💼 other general
⌚ 2 days ago

🔖 Full Time

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CMC2 - Regulatory Affairs - Animal Health

🔖 Full Time

📑 Role: CMC2 - Regulatory Affairs - Animal Health Type: Contract Contract Location: Rahway, NJ - Onsite from day 1 (locals only) Contract Duration: 11 months Hourly Pay Rate: $44 W2 and $52 C2CResponsibilities: Well versed in ...

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Senior Director Regulatory Affairs

🔖 Full Time

📑 The Brands and Innovative Medicines Global Regulatory Affairs organization is seeking a Senior Director, Global Regulatory Portfolio Leader. Working with leaders across the organization, this individual will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas and develop a te ...

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Director, CMC (Recombinant Proteins)

🔖 Full Time

📑 For our Biopharmaceutical Product Development (CMC) department, we are looking for aDirector, CMC (Recombinant Proteins) (m/f/x)Fulltime / permanent/ non-tariffR-228207The OpportunityAs Director, CMC (Recombinant Proteins) you will lea ...

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(Senior) Director – Regulatory Affairs (Companion Diagnostics)

🏢 QIAGEN
📌 United States, United States, United States
💼 other general
⌚ 23 hours ago

🔖 Full Time

📑 Overview At the heart of QIAGEN’s business is a vision to make improvements in life possible. We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many ...

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Associate Regulatory Affairs-CMC

🏢 Ampcus Incorporated
📌 Thousand Oaks, California, , United States
💼 other general
⌚ 1 days ago

🔖 Full Time

📑 What we are looking for:Desire to learn Regulatory Affairs CMC and global submission strategyStrong organizational skills with attention to detailProficient time management skills and ability prioritize workloadAbility to work both independently and as a member of a tea ...

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Associate Director, Regulatory Affairs – Therapeutic Area Strategy

🏢 Ferring Pharmaceuticals
📌 United States, New Jersey, United States
💼 other general
⌚ 10 days ago

🔖 Full Time

📑 Job Description:As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remain ...

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Head of Regulatory Affairs

🔖 Full Time

📑 Lead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next.Be the go for all things regulatory and acting as a key voice to the future of all trials, SOPs and s ...

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Director of Regional Regulatory Vaccines Lead

🔖 Full Time

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Regulatory Affairs Consultant

🏢 Katalyst Healthcares &amp; Life Sciences
📌 Plainsboro, New Jersey, , United States
💼 management
⌚ 0 hours ago

🔖 Full Time

📑 Responsibilities: Provides strategic global regulatory guidance to cross-functional project teams responsible for product development. Actively leads the development and implementation of regulatory strategies for assigned programs and ensures cross-functional alignment. <br ...

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Senior Manager Regulatory Affairs

🔖 Full Time

📑 SummaryThis position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation syste ...

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Clinical Strategy Senior Lead - REMOTE

🏢 Zimmer Biomet
📌 United States, United States, United States
💼 other general
⌚ 12 days ago

🔖 Full Time

📑 At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.As a Zimmer Biomet team member, you will share in our commitment to providing mobility and ...

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Senior Director, Drug Product

🔖 Full Time

📑 Senior Director, Drug ProductDirect Hire Full-Time RoleSalary Range: $224,600 - $245,000 per yearLocation: Redwood City, CA - Hybrid RoleJob Summary:Playing a critical role as the drug product technical lead and CMC project lea ...

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Senior Director, Drug Product

🔖 Full Time

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Sr. Director Toxicology

🔖 Full Time

📑 The CompanyDelix Therapeutics is a neuroscience company focused on harnessing the power of psychoplastogens—novel neuroplasticity-promoting therapeutics—to treat brain health disorders. Delix is advancing these compounds through preclinical and clinical development to bring patients FDA-approved medicines that will addres ...

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Program Manager (Drug Development)

🔖 Full Time

📑 Program Manager - Business Professional5 Month Initial ContractCambridge, MA - Hybrid - onsite 2-3 days/weekMax PR: $94.21 MUST HAVE'sBachelor’s Degree in Science or Business | MS preferred </li ...

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CMC Regulatory Affairs Program Manager

🏢 Katalyst Healthcares &amp; Life Sciences
📌 Cambridge, Massachusetts, , United States
💼 management
⌚ 9 days ago

🔖 Full Time

📑 Responsibilities: Responsible to communicate new regulatory guidelines. Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and standards are properly and timely implemented. Provide support to Regulat ...

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Regulatory Affairs Senior Manager

🔖 Full Time

📑 Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Senior Manager for a FULL TIME assignment with one of our premier Pharmaceutical Services clients in Hawthorne, NY.Responsibilities: ...

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