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Dennis Partners
Boston, MA, United States
This clinical-stage company is advancing innovative therapies for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director who can develop and execute on global regulatory strategies for a quickly-advancing clinical stage Rare Disease program. In this role, you will work closely with cross-functional teams and Heal
Job Source: Dennis PartnersDyne 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 muscl
Job Source: Dyne Therapeutics IncRelay Therapeutics
Cambridge, MA, United States
The Opportunity: We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the global regulatory lead on relevant project teams to
Job Source: Relay TherapeuticsBiofourmis
Needham, MA, United States
The Director of Quality and Regulatory Affairs is responsible for developing and implementing the long range regulatory and compliance strategy by leading and directing the organizational development, processes and activities required to support the Biofourmis remote patient monitoring platforms and pharma partnerships on a global basis. Reporting
Job Source: BiofourmisLantheus
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: LantheusDyne 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 IncAzurity Pharmaceuticals - US
Woburn, MA, United States
Direct the activities of US Labeling and Advertising/Promotional Review Teams. Responsible for the oversight of labeling for product registration and commercialization.Ability to provide Advertising/Promotional regulatory insight in line with applicable regulatory guidelines. Serve as a liaison and subject matter expert (SMA) on the interpretation
Job Source: Azurity Pharmaceuticals - USLantheus
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
Our client is a clinical stage biopharmaceutical company. They have asked us to assist them in their search for a
Director, Regulatory Affairs.
Major tasks and responsibilities include:
Supports global regulatory strategy and execution on development programs, including maintaining strong relationships with cross-functional internal colleagues, regulatory agencies, CROs, consulting groups, and other third parties.
Provides strategic regulatory leadership and guidance to project teams. Ensure clinical trials are designed to meet regulatory requirements.
Collaborates with various departments such as R&D, Quality, Clinical, and Manufacturing to ensure alignment with regulatory requirements throughout the product lifecycle.
Ensures operations are compliant with applicable FDA, ICH, EMA, and industry standards.
Proactively identifies regulatory opportunities and risks and mitigate effectively.
Contribute to the development of the overall nonclinical and clinical development strategy by providing regulatory insights and guidance at all stages of product development.
Seeks innovative and creative operational solutions that comply with regulations and are sound from business and scientific perspectives. Provides contingencies and alternate approaches to leadership and/or partners to resolve any development program challenges from preclinical (pre-IND) to Phase 1 through approval.
Supports the preparation of key health authority submissions and interactions. Assures consistent positions on common issues are presented and drives the development and on time completion of health authority background documents and responses to inquiries.
Develops content and formats for regulatory submissions, such as INDs.
Coordinates and prepares responses to requests for information from regulatory authorities.
Authors, reviews, and/or edits relevant regulatory documents e.g., clinical development plans, protocols, informed consent, IBs.
Stays abreast of regulatory requirements, trends, and changes and informs senior leadership as necessary.
Participates in setting and meeting departmental goals, developing team members, and fostering a culture of excellence.
We seek candidates with the following qualifications:
Significant regulatory affairs experience is required. Experience with taking a program through key development milestones with global regulatory bodies is highly preferred.
Experience with rare disease, neuromuscular, or neurodegenerative therapies is strongly preferred.
Must have a comprehensive knowledge of the drug development process, global regulations and guidelines, and a comprehensive understanding of global regulatory agencies.
Must have proven success interacting with regulatory bodies.
Requires a full functional knowledge of regulatory requirements pertaining to the development and registration of drug products.
Must be able to solicit information, persuade others, and shape outcomes favorable to the company's goals and objectives.
Must be highly proficient in communicating and presenting strategic and tactical issues to all levels, including top management and regulatory agencies.
Demonstrated project management skills and organizational skills are required.
Must be willing to roll up sleeves and be hands-on.
Effectively recommends and implements solutions to problems.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon's list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms .
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Email Alert for Director, Regulatory Affairs jobs in Boston, MA, United States
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