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Dyne Therapeutics Inc
Waltham, MA, United States
Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle
Job Source: Dyne Therapeutics IncAzurity Pharmaceuticals - US
Winchester, MA, United States
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad com
Job Source: Azurity Pharmaceuticals - USApellis Pharmaceuticals
Waltham, MA, United States
Position Summary: The Director, Regulatory Affairs will be responsible for ensuring the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategies for accountable program(s). Key Responsibilities Include: Ensure alignment of global regulatory strategies with Apellis corporate objectives. Collaborate wit
Job Source: Apellis PharmaceuticalsRapport Therapeutics
Boston, MA, United States
As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition
Job Source: Rapport TherapeuticsJRG Partners
Boston
Job Description Job Description Job Title: Director of Regulatory Affairs Job Description: As the Director of Regulatory Affairs in the medical device industry, you will play a pivotal role in ensuring that our products comply with all applicable regulatory requirements and standards. Leveraging your extensive knowledge of regulatory processes,
Job Source: JRG PartnersDyne Therapeutics Inc
Watertown, MA, United States
Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscl
Job Source: Dyne Therapeutics IncX4 Pharmaceuticals
Boston, MA, United States
Director, Regulatory Affairs Reporting to: Vice President, Regulatory Affairs Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite you to be a part of a patient-focused company developing potential new treatment
Job Source: X4 PharmaceuticalsLantheus
Bedford, MA, United States
Description Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organiza
Job Source: LantheusBoston, MA, United States
Regulatory Affairs Director - Permanent - Boston, MA
Proclinical is seeking a Regulatory Affairs Director who will be responsible for the development and execution of regulatory strategies for assigned programs. This is a permanent position based in Boston, MA.
Primary Responsibilities:
The successful candidate will work collaboratively with various teams to bring innovative and compliant approaches to the development and maintenance of our products. This role requires a strategic thinker who can continuously adapt regulatory strategies, provide regulatory input into product profiles, and ensure the flawless execution of global regulatory plans.
Skills & Requirements:
Advanced degree in a scientific discipline such as Pharmacy, Medicine, Chemistry, Biological Sciences.
Proven experience in drug development and managing complex worldwide products/projects within a relevant therapeutic area.
Excellent written and oral communication skills.
Solid project management skills.
Strong interpersonal and negotiation skills.
Strategic thinking and ability to derive creative solutions to regulatory problems.
Proven ability to lead change and communicate difficult messages effectively.
The Regulatory Affairs Director will:
Develop and implement regulatory strategies for assigned programs.
Provide regulatory input into target product profiles and Integrated Asset Strategic Plans.
Continuously evaluate and adapt development objectives and plans in line with new findings and regulatory requirements.
Define strategy for regulatory consultation and advocate for proposed strategies to senior leaders.
Identify potential risks and propose mitigation options.
Ensure flawless execution and implementation of global regulatory plans.
Conduct regulatory due diligence assessment on external opportunities.
Lead operational excellence initiatives within the Regulatory Affairs department.
If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 or [email protected] .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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Email Alert for Regulatory Affairs Director jobs in Boston, MA, United States
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