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Director of Regulatory Affairs – Cambridge

The Director of Regulatory Affairs is responsible for defining and implementing regulatory strategies to obtain global approvals of new/modified devices and combination products to support business objectives.


Location – Cambridge Massachusetts

Description:

The role of Director of Regulatory Affairs requires the ability to analyze complex technical and medical information and formulate strong regulatory arguments that can be defended with regulatory agencies such as the FDA and international Health Authorities.

Responsibilities:


-Work closely with Marketing, R&D, Manufacturing, and Clinical Affairs, develop the regulatory strategy to gain market approval for new or modified devices/combination products consistent with corporate objectives.


- Lead the preparation of complex submissions including PMAs, NDAs, BLAs.INDs, IDEs, Notified Body/Competent Authority application, Health Canada licenses, and submissions to other international Health Authorities.

-Interact proactively and persuasively with global regulatory agencies in order to gain approvals.

-Ensure all national registrations, licenses, listing, and other certifications are maintained as required for regulatory compliance.

-Hire, manage, and develop staff of regulatory professionals in the U.S.

-Contract and manage specialized regulatory consultants as necessary.

-Accountable for developing and meeting regulatory timelines and budgets.

Qualifications & Skills:

-BA/BS in the life sciences, or engineering with MS preferred

-Requires 10+ years of regulatory experience in the medical
device/pharmaceutical/biologics industry.

-5+ years of managerial experience required including direct supervisory experience and experience building/meeting budgets and timelines.

-Experience developing and successfully defending complex regulatory submissions for medical devices and combination devices (IND, NDA).


-Requires strategic leadership, strong communication and persuasion skills, and the ability to craft strong regulatory arguments.

-Line management experience


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Senior Director Regulatory Affairs - Boston 

The Senior Director of Regulatory Affairs will be accountable for leading the development and execution of global regulatory strategies for innovative medicines for rare diseases. A successful candidate will maintain focus on corporate goals while responding to the needs of project teams in a highly dynamic, fast-moving environment. 


Location – Cambridge Massachusetts

Responsibilities:


- Initiate and lead the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure regulatory requirements and strategy are understood by project teams.


- Preparation, review and submission of high-quality documentation for INDs, CTAs, NDAs, BLAs, MAAs, and related filings to Regulatory Agencies within established timeframes.


- Serve as FDA liaison and provide leadership and support for Regulatory Agency meetings and teleconferences.

- Maintain up-to-date knowledge on international and domestic regulatory requirements.


Qualifications & Skills:


- 10+ years of increasing responsibility in pharmaceutical or biotech.


- Rare disease experience preferred


- Track record of successful IND, CTA, NDA, and/or BLA submissions


- Ability to blend analytical and critical-thinking skills to enable data-driven, strategically oriented review of regulatory documents




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Director of Global RA CMC - New York


Cutting edge Biotech leading the way in Gene Therapy looking for an experienced RA CMC professional to lead their Global CMC function.


Location – New York city 

Responsibilities:


–CMC supports the success of our AAV and LVV gene therapy
programs by serving as the global product leader for CMC regulatory strategy.


-Manage multiple Regulatory CMC projects by coordinating
with both internal and external stakeholders. 


-S/he will formulate and implement global CMC regulatory strategies for the development of gene therapy programs that are in line with global requirements, and coordinate all aspects of CMC regulatory submissions relevant to assigned projects or programs.

Qualifications & Skills:


-BA/BS/University
degree in Life/Health Sciences required; advanced degree preferred

-Several years’ experience in regulatory CMC and/or viral vector gene therapy technical product development (process, formulation, analytical, quality) preferably in the biotechnology/biopharma industry.

-Experience and knowledge in the preparation of CMC content for major global regulatory submissions including INDs, CTAs, license applications, and meeting briefing packages

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Senior Regulatory Manager CMC - Boston

The Senior Manager of Regulatory CMC will manage complex projects for compiling global regulatory CMC strategy and submissions.  In addition this role will manage the collection and submission of GMP documents for global clearances and accreditations of manufacturing, testing, and packaging/labeling sites.


Location – Cambridge Massachusetts

Description:

- Dependently manage multiple projects and submissions in support of commercial and investigational products.

- Plan, coordinate, and manage the development, preparation and submission of the CMC sections of the registration dossiers, supplements, and renewals for commercial products. Dossier preparation will include new country submissions and post-approval changes.

- Develop proactive regulatory strategies for global CMC product lifecycle management, with limited oversight. Present CMC strategies and plans to Alexion management and appropriate core teams.

- Partner with Manufacturing, Quality, Technical/Analytical Development and Research to develop the CMC CTD content and ensure compliance with global health authority requirements in preparation for licensure. Provide guidance and expertise on assigned RA-CMC documents/projects.

- Ensure that appropriate CMC documentation is filed and archived in designated systems.. 


Responsibilities:


-Work closely with Marketing, R&D, Manufacturing, and Clinical Affairs, develop
the regulatory strategy to gain market approval for new or modified
devices/combination products consistent with corporate objectives.

- Lead the preparation of complex submissions including PMAs, NDAs, BLAs.INDs,IDEs, Notified Body/Competent Authority application, Health Canada licenses,and submissions to other international Health Authorities.

-Interact proactively and persuasively with global regulatory agencies in order to gain approvals.

-Ensure all national registrations, licenses, listing, and other certifications are maintained as required for regulatory compliance.

-Hire, manage, and develop staff of regulatory professionals in the U.S.

-Contract and manage specialized regulatory consultants as necessary.

-Accountable for developing and meeting regulatory timelines and budgets.

Qualifications & Skills:

- At least 8 years related experience in a scientific discipline with additional technical / project education or training; with a minimum of 5 years of experience in Regulatory and/or, Regulatory-CMC.

- Bachelor’s degree in relevant scientific discipline.

- Strong written and oral communication skills; comfortable communicating with and building relationships with numerous stakeholders in a cross functional environment.

- Candidate is required to have a broad functional knowledge of pharmaceutical sciences / the Biopharmaceutical industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.

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