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Associate Director of RA Strategy– Cambridge

Regulatory Connect has partnered with one of the most excicitng companies in Cambridge who boast one of the most diverse portfolio's of development and commercial products. They are looking for excellent Regulatory candidates with a strong scientific background who can execute global Regulatory strategy for early and late phase products.

This position will suit anyone with a strong background in Global RA strategy for INDs/NDAs/BLAs who can act as GRL for assigned products.

Your role:

Assume the role of Global Regulatory Lead (GRL) for specific products.
Contribute to proactively formulating regulatory strategies that provide a streamlined development and approval time line while accurately interpreting and reflecting regulatory and Corporate guidelines.
Assist with planning, preparation for and conduct of meetings with Regulatory agencies for all assigned products.
Ensure that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance.
Guide project teams to implement appropriate regulatory strategies.
Supervise and coordinate all regulatory activities required for submissions to regulatory agencies for assigned products.

Education and Skills Requirements: 

Demonstrated knowledge of drug development process is essential. Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.
Experience with preparing IND submissions and briefing packages for regulatory meetings essential.
Experience with successful NDA, sNDA and/or BLA filing preferred.
Prior experience working with EMA preferred.

Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field minimum, with 5 years regulatory experience. Demonstrates personal leadership, with a natural ability to bring divergent views together, agree common objectives and engenders enthusiasm even in challenging circumstances.

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Senior Director Global Regulatory Labeling - PA

Regulatory Connect is working in partnership with a biopharmaceutical company focused on developing and commercializing innovative medicines across a diverse range of therapy areas They are a well establised biotech with many commercial products and a huge portfolio of development drugs within rare disease.

They are looking to hire a Senior Director (Head of Global Labeling) to lead the Global Labeling function within Global Regulatory Affairs and have overall responsibility for the worldwide labeling portfolio.

Your role:

In this leadership position, the Head of Global Labeling provides labeling guidance / perspective to respective governance bodies, advocates for company positions and coaches/mentors departmental members in technical and leadership attributes .

As the business owner for the labeling review/approval process, the Head of Global Labeling ensures the optimal development / implementation of said processes and supports revisions to these processes to enable continuous improvement.

Engages cross-functionally with key stakeholders in Global Safety, Clinical Research, Commercial Development and GRA regional/global functions to ensure business critical objectives are met and scientific, regulatory compliant labeling is provided to customers

Manages a team of global labeling professionals and provides mentors department in Leadership behaviors.

Develops global labeling strategies to enable business objectives while optimizing product benefit/risk information for users and prescribers.

Education and Skills Required:

At least 10 years of regulatory experience, with focus on global labeling, and previous managerial experience (7+ years). Overall pharmaceutical /industry experience should exceed 15 years.
Broad knowledge of and experience with regulatory product labeling requirements and risk minimization
Experience working in a complex and matrix environment is required

Demonstrated experience in working with multiple stakeholders.

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Senior Director RA - Advertising and Promotion 

Regulatory Connect is working in partnership with a biopharmaceutical company focused on developing and commercializing personalized Oncology drugs to treat patient. They are fast approaching commercialization and are looking for a Director/Senior of Regulatory Affairs - Advertising & promotion to provide strategic guidance on the development and implementation of a creative and compliant advertising and promotion program for their pre-launch and commercial oncology and rare-disease portfolio.

Your role:

Serves as the primary regulatory advertising and promotion reviewer on cross-functional Promotional Review Boards for the successful launch of commercial programs, and on Medical Review Boards for the compliant scientific exchange of information of Blueprint's investigational programs.
Acts as primary contact with FDA's Office of Prescription Drug Promotion including responding to agency inquiries and managing company requests for advisory review.
Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks.
Works closely with Regulatory counterparts to ensure that global development strategies result in commercially viable labeling, in support of desired promotional claims.
Monitors and keeps organization up-to-date on US regulatory promotional environment

Education and Skills Required:

BA/BS Degree required
Advanced degree preferred (MS, PhD, PharmD, or JD)
A minimum of 10 years of pharmaceutical industry experience, with at least 7 years of experience focused on the regulatory review of advertising and promotion materials for prescription drug products
Experience with launching new products and/or new indications a must; with experience in oncology and/or rare diseases.
Direct experience interacting with OPDP required
Experience working on an accelerated approval product a plus.

Strong interpersonal and oral and written communication skills

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Director of Global Regulatory CMC - Remote

Regulatory Connect has partnered with a clincal stage Biopharma who have a very strong early stage development portfolio of Oncology products. This is a fully home-based role and can be offered from anywhere in The US, preference will be given to East Coast candidates.

This position will suit anyone with a strong background in RA CMC small molecule, Global CMC strategy and experience interacting with Health Authotities.

Your role: 

Lead preparation and filing of Global regulatory CMC section of assigned IND, CTA and NDA submissions and manage the interactions with FDA, EMA and other authorities for CMC topics.
Provide regulatory support and guidance to cross-functional teams and ensure all applicable global regulatory CMC requirements are considered and appropriately incorporated into clinical and commercial products.
Ensure CMC is cGMP and ICH guidance compliance. Assess CMC planned changes during development and provide guidance to CMC and report to health authorities as appropriate.
Function as RA CMC representative in development project team.
May lead FDA meetings on CMC issues.

Education and Skills Required:

- Industry experience (not agency)
- Strong small molcule (majority small mol not biologics)
- Global RA CMC strategy
- Strong interaction with Health Authorities.
- Strong Communicator
-BS in Life Sciences or Chemistry required; advanced degree highly preferred
-7+ years of pharmaceutical or biotech industry experience
-5+ years of hands-on regulatory affairs CMC experience-
-Experience in authoring and reviewing eCTD CMC documents for small molecule innovative drug
-Experience in regulatory CMC for early and late development projects.
-Experience with FDA inspection and internal audit.

-Experience with FDA is essential and global experience is highly preferred.

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