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📑 Position Title: Vice President of Medical AffairsIndustry: BiotechnologyEmployment Type: Full-timeLocation: Boston Massachusetts Equal Employment Opportunity: This company is an equal opportunity employer and is committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual ...

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📑 Position Title: Vice President of Medical AffairsIndustry: BiotechnologyEmployment Type: Full-timeLocation: Boston Massachusetts Equal Employment Opportunity: This company is an equal opportunity employer and is comm ...

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📑 Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the ...

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📑 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 strategy for these ...

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📑 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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📑 Head, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; Innovative CRO – Remote – Retained SearchSummary:Cornerstone Search Group has been retained by a rapidly growing Clinical Research Organization funded by a thriving multi-billion-dollar parent Health Care Company. The Head of Corporate & Legal Affairs will report directly to the ...

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📑 Head, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; Innovative CRO – Remote – Retained SearchSummary:Cornerstone Search Group has been retained by a rapidly growing Clinical Research Organization funded by a thriving multi-billion-dollar parent Health Care Company. The Head of Corporate & Legal Affairs will report directly to the ...

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📑 Head, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; Innovative CRO – Remote – Retained SearchSummary:Cornerstone Search Group has been retained by a rapidly growing Clinical Research Organization funded by a thriving multi-billion-dollar parent Health Care Company. The Head of Corporate & Legal Affairs will report directly to the ...

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📑 Head, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; Innovative CRO – Remote – Retained SearchSummary:Cornerstone Search Group has been retained by a rapidly growing Clinical Research Organization funded by a thriving multi-billion-dollar parent Health Care Company. The Head of Corporate & Legal Affairs will report directly to the ...

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📑 Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple ar ...

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📑 Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas ...

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📑 Director of Policy & Regulatory Affairs | Eastern US, REMOTE |$165k - $175k base + bonusAre you a regulatory affairs and energy policy professional with experience in the RTOs (PJM), FERC and State Commissions?Are you looking for an opportunity to join a small, well-backed, company on the cutting edge of the clean energy transition?Do you enjoy kee ...

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📑 Head, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; Innovative CRO – Remote – Retained SearchSummary:Cornerstone Search Group has been retained by a rapidly growing Clinical Research Organization funded by a thriving multi-billion-dollar parent H ...

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📑 Head, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; Innovative CRO – Remote – Retained SearchSummary:Cornerstone Search Group has been retained by a rapidly growing Clinical Research Organization funded by a thriving multi-billion-dollar parent H ...

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📑 Head, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; Innovative CRO – Remote – Retained SearchSummary:Cornerstone Search Group has been retained by a rapidly growing Clinical Research Organization funded by a thriving multi-billion-dollar parent H ...

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📑 Head, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; Innovative CRO – Remote – Retained SearchSummary:Cornerstone Search Group has been retained by a rapidly growing Clinical Research Organization funded by a thriving multi-billion-dollar parent H ...

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📑 Director of Policy & Regulatory Affairs | Eastern US, REMOTE |$165k - $175k base + bonusAre you a regulatory affairs and energy policy professional with experience in the RTOs (PJM), FERC and State Commissions?Are you looking for an opportunity to join a small, wel ...

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📑 Our client is seeking a Sr. Director, Clinical Regulatory Affairs to develop regulatory strategies for both non-clinical and clinical programs and lead interactions with regulatory authorities. Reporting to the SVP, Head of Regulatory Affairs, this role will have significant strategic oversight of various submissions and will be the global regulato ...

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📑 Senior Manager/Associate Director, Regulatory StrategyCompany Overview:Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the b ...

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📑 Location: Boston, MA (Remote)Therapeutic Areas: NeuroJob Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation, amendments, and maintenance activities in a collaborative team environment.Primary Job Respo ...

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📑 Hays's recently been engaged with a Biotech Company for the search of a Vice President, Head of Regulatory Affairs in the Boston Area. - Full time Role - Role in the Boston Area. (Open to discuss if it's East Coast Based) - Reporting to the CMO of the company. Requirements: • Bachelor’s degree in a scientific discipline; Graduate degree (Ph.D. or P ...

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📑 Our client is seeking a Sr. Director, Clinical Regulatory Affairs to develop regulatory strategies for both non-clinical and clinical programs and lead interactions with regulatory authorities. Reporting to the SVP, Head of Regulatory Affairs, this role will have significant strategic oversight of various submissions and will be the global regul ...

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📑 Job Title: Quality and Regulatory Project ManagerGabriele & Company, recruiters for manufacturing and supply chain professionals, is assisting a globally renowned, small medical device company whose products are used in nearly half of all hospitals in the US. This world leader in their market niche is seeking an exceptional Quality and Regulatory P ...

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📑 Walker Cole International is searching for a QA/RA Specialist to join a Global Medical Device business in Massachusetts, Boston. As part of this role you will manage a the regulatory compliance of a range of medical devices including IVD's (In Vitro Diagnostics) focussing on ensuring compliance through QMS management and complaint management.Your r ...

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📑 Associate Director, Regulatory Affairs - Boston, MA - PermanentProclinical is seeking a strategic regulatory leader to join a renowned biotech. This is a permanent position located in Boston, MA.Primary Responsibilities:The primary focus of this role is to work with int ...

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📑 Hays's recently been engaged with a Biotech Company for the search of a Vice President, Head of Regulatory Affairs in the Boston Area. - Full time Role - Role in the Boston Area. (Open to discuss if it's East Coast Based) - Reporting to the CMO of the company. Requirements: • Ba ...

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📑 Associate Director, Regulatory Affairs - Boston, MA - PermanentProclinical is seeking a strategic regulatory leader to join a renowned biotech. This is a permanent position located in Boston, MA.Primary Responsibilities:The primary focus of this role is to work with internal and external stakeholders to ensure the timely release of finished product ...

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📑 Location: Boston, MA (Remote)Therapeutic Areas: NeuroJob Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation, amendme ...

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📑 Senior Manager/Associate Director, Regulatory StrategyCompany Overview:Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculatur ...

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📑 Walker Cole International is searching for a QA/RA Specialist to join a Global Medical Device business in Massachusetts, Boston. As part of this role you will manage a the regulatory compliance of a range of medical devices including IVD's (In Vitro Diagnostics) focussing on ensuring compliance through QMS management and complaint management.</p ...

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📑 Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as ...

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📑 Job Title: Quality and Regulatory Project ManagerGabriele & Company, recruiters for manufacturing and supply chain professionals, is assisting a globally renowned, small medical device company whose products are used in nearly half of all hospitals in the US. This world leader in their market niche is ...

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📑 This position will be the Regulatory lead on the company's highest profile asset. This organization is mid-sized, and has seen significant success with multiple approved products and continued innovation in areas of small molecules, biologics and gene therapy - all with a focus on rare disease!Responsible for providing global regulatory leadership ...

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📑 The Regulatory Affairs Intern will support the Regulatory Affairs team in daily tasks, projects, and FDA submission activities including:Assist in drafting, organizing, and editing regulatory documents for 510(k) submissions. Coordinate workflow for regulatory document reviews (internal an ...

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📑 This position will be the Regulatory lead on the company's highest profile asset. This organization is mid-sized, and has seen significant success with multiple approved products and continued innovation in areas of small molecules, biologics and gene therapy - all with a focus on rare disease!Responsible for providing global r ...

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📑 PepGen is a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this technology across a wide range o ...

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📑 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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📑 Careers that Change Lives A career at Medtronic is like no other. We’re ...

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📑 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 patients worldwide.Join ...

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📑 Our client is a leading biotechnology company dedicated to advancing innovative therapies in the fields of oncology, transplantation, and cellular therapy. We are committed to improving patient outcomes and transforming the landscape of medical care through groundbreaking research and development efforts. As we continue to expand our portfolio of c ...

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📑 Director, Regulatory Strategist – Global Regulatory Lead (Hybrid)  Position Summary   PepGen is at an exciting time in our development. Reporting into the VP Head of Regulatory, you will be responsible for the global regulatory strategic development for one of our lead assets, providing a unique opportunity for a motivated and ...

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📑 PepGen is a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this technology across a wide rang ...

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📑 Title: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development ...

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📑 Our client is a leading biotechnology company dedicated to advancing innovative therapies in the fields of oncology, transplantation, and cellular therapy. We are committed to improving patient outcomes and transforming the landscape of medical care through groundbreaking research and development efforts. As we continue to expand our portfolio o ...

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📑 Director, Clinical Operations (Hybrid in Boston, MA) Salary: $220,000- $245,000This company is a pioneering biotechnology company dedicated to advancing the field of gene therapy to address unmet medical needs and transform the lives of patients worldwide. Founded on the principles of innovation, collaboration, and patient-centricity, they are comm ...

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📑 Title: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a m ...

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📑 Director, Clinical Operations (Hybrid in Boston, MA) Salary: $220,000- $245,000This company is a pioneering biotechnology company dedicated to advancing the field of gene therapy to address unmet medical needs and transform the lives of patients worldwide. Founded on the principles of innovation, collabo ...

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📑 RWE Lead - Contract - RemoteProclinical is seeking a Real World Evidence (RWE) Lead who will provide clinical leadership for evidence generation activities, supporting the integration of RWE into key strategic initiatives. This is a remote contract position.Primary Responsibilities:This role functions in a matrix team environment, interacting with ...

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📑 Recent Pharma/ CRO experience requiredRegulatory Operations ContractorRegulatory AffairsLocation(Boston)Contract Term: Contract through EOY with possible extension Should have strong Word ...

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📑 Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s) Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures and listings (TFLs) in a timely and high-qual ...

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