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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 PartnersRelay 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: BiofourmisDyne 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 IncDyne 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 - USFairway Consulting Group
Boston, 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, r
Job Source: Fairway Consulting GroupLantheus
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
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 and a passion to create impactful neuromedicines, with fewer side effects, that allow patients and their families to live healthier and more fulfilling lives.
On a molecular scale, our deep understanding of the intricate relationships between receptors, their associated proteins, and their distributions in specific cell types and brain regions enables us to precisely direct medicines to the neural circuits underlying disease pathophysiology.
Rapport has an exciting opportunity to join our growing regulatory team. This Director of Regulatory Affairs will report directly to the Vice President of Regulatory Affairs and will hold a crucial role developing the regulatory strategy and tactics for assigned programs.
Responsibilities:
Create and implement innovative and effective regulatory strategies to support the development of Rapport global drug development programs
Provide regulatory expertise and advise to cross-functional team members including clinical, CMC, clinical pharmacology, and nonclinical
Accountable for the maintenance of regulatory applications such as INDs, CTAs, NDAs, etc.
Identify regulatory risks and mitigation plans
Serve as the regulatory lead on project teams
Ensure compliance with local and international submission requirements, manage CROs as applicable.
Represents Rapport as the point of contact for regulatory health authorities, as assigned ensuring exemplary ethics and transparency within the company and with health authorities
Keeps current with global regulatory landscape and advises project teams on potential impact to programs
Provide mentorship and support to junior team members to foster their professional growth and development
Qualifications: Bachelors degree in a life science or related discipline
10 years of experience in the pharmaceutical industry
Experience in neurology and small molecules preferred
Must have experience with submission of new molecular entity INDs. NDA experience preferred but not required.
Global drug development experience
Ability to manage competing priorities, influence and integrate within a team, manage timelines, deliver on corporate and program goals.
Must have good interpersonal skills and fit in with Rapport culture
Must demonstrate strong leadership and team building skills, including experience with conflict resolution and real time problem solving.
Thorough understanding of the development phases within a fast-moving biopharmaceutical organization
Exceptional written and verbal communication skills
Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
CCPA disclosure notice can be found here.
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Email Alert for Director, Regulatory Affairs jobs in Boston, MA, United States
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