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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 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 IncFairway 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 GroupAzurity 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
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 Health Authorities to advance key programs and support an upcoming BLA. This company offers innovative science and a collaborative, patient-focused company culture. With their lead programs in Phase 1/2 studies, now is an exciting time to join this growing organization!
Responsibilities:
Drive global regulatory strategy and operational activities for a Phase 1/2 rare muscular disease program.
Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc)
Interact with regulatory colleagues and other departments to develop regulatory strategy and submission plans for quality and timely filings.
As a member of program teams, provide global regulatory guidance regarding requirements for clinical development and registration of pharmaceuticals.
Oversee preparation, review, and submission of regulatory documents, maintaining compliance with regulatory requirements.
Manage timelines and preparation of meeting requests and briefing documents.
Interact with FDA and other regulatory agencies in conjunction with senior Regulatory leaders.
Author/edit documents to support regulatory submissions.
Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements
Manage and ensure compliance with all reporting requirements, including annual and periodic reports
Prepare for meetings with FDA and other health authorities.
Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management.
Contribute to improvements in department best practices and SOPs.
Perform other duties as required, interfacing with other departments, CROs and external vendors as needed
Qualifications: Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
Eight or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologic therapeutics.
Regulatory experience with Rare Disease programs highly desired. Experience with neurology/CNS programs a plus but not required.
Must have experience working directly with FDA and other Health Authorities (EMA, Health Canada, Japan, etc).
Experience in designing, writing, and submission of regulatory filings (INDs, CTAs, NDAs/BLAs, ODAs, etc).
Experience with Accelerated Approvals, Fast Track, and Breakthrough designations a plus.
Strong understanding of the global pharmaceutical drug development and regulatory environment.
Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plus.
Must have experience preparing for and participating in Health Authority meetings.
Excellent oral and written communications skills.
Strong interpersonal skills, including conflict management and negotiation skills.
Willing to roll up sleeves and do whatever is needed to ensure Regulatory success.
Must be flexible and comfortable with ambiguity in a fast-paced, small company environment.
This is an onsite position in the Greater Boston area.
The budgeted salary range for this position is US$200,000 to $240,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.
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Email Alert for Regulatory Affairs Director jobs in Boston, MA, United States
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