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Director/Senior Director Regulatory Affairs - PA

Our client is an established and very well respected Biotech organisation based in Greater PA. They are seeking a Director/Senior Director Regulatory Affairs to implement and execute their Global Regulatory Strategy . With a focus on rare disease and a true passion for science, this organization prides itself on its historical achievements within a range of therapeutic areas.

-Serve as RA liaison between Regulatory Affairs and other functional areas.
-Responsible for leading Therapy Group and managing team.
-Represent RA in various team meetings (including Product Development Teams)
-Managing regulatory compliance/conformance and identifying any potential regulatory risks.
-Oversight of Regulatory submission for both early, late and approved products.
-Leading health authority meetings.
-Acting as key point of contact for regulatory agencies.
-Global (most senior) lead for specific therapy area.

-Strong communication and organization skills.
-Ability to interpret regulatory documents and provide robust regulatory strategy.
-Knowledge of FDA (CBER) requirements related to submission of regulatory documents for biologics/drug approval.
-Prior involvement in FDA interaction and documentation preparation.
-Minimum of a Bachelor’s degree in a scientific field & 10+ years of regulatory experience

-Experience with biologic's and rare disease is big plus.

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Associate Director Regulatory Strategy - Cambridge 

Regulatory Connect have been lucky enough to partner with an innovative Oncology focused Biopharma company who specialize in personalized medcines. They have a strong portfolio of development and commercial prodcuts and are nearing the commercialization of two more Oncology products.

They are looking to recruit at the Senior Manager/Associate Director level, you will support the development and execution of global regulatory strategies to advance their portfolio, great opportunity to work on both early and late phase products with a company voted as one of the best places to work in MA.

Primary Responsibilities: 
-Responsible for day-to-day management of regulatory aspects of at least one clinical development program.
-Responsible for managing and completing relevant submissions for assigned program(s), including but not limited to: an IND, CTAs, NDAs, annual reports, safety reports etc.
-Represent the Regulatory Affairs function on cross functional teams
-Support manager in developing and implementing long and short-term product regulatory strategies/plans
-Provide guidance to external programs vendors and consultants

About You: 
-Bachelor’s degree; advanced scientific related degree a plus.
-A minimum of 4 years of regulatory drug development experience.
-Experience in rare disease or oncology drug development preferred.
-Must have experience filing INDs; CTAs and marketing application experience a plus.

-Solid working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, and ROW regulatory requirements a plus

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Senior Director RA - T-Cell Immuno-Oncology - NJ

We have partnered with a very innovative, clinical stage Biotech who have a strong portfolio of T- Cell, immuno-oncology products at early and late phase. They are currently conducting the largest Phase III trial for any T-Cell immunotherapy cancer indication. Their mission is to cure cancers and save lives with innovative and widely accessible immunotherapies.

The Director/Senior Director defines appropriate regulatory strategies to support successful global clinical development plans with focus in the US.

Primary Responsibilities:

● Provides regulatory support to inter-departmental project team
● Works with global regulatory team members to agree contents for timely submissions to Health Authorities.
● Responsible for coordinating the preparation and regulatory review of documents for regulatory submissions from all areas of the company
● Ensures that data provided are presented clearly and succinctly to optimize the regulatory review and approval process.

● Liaise with FDA and other health authorities as needed.
● Coordinates the preparation of responses to questions and inquiries from Health Authorities. ● Prepares and submits IND amendments, safety reports and DSUR in accordance with regulatory submission schedules and regulations

About You:

● Director requires a minimum of 8 years experience in regulatory affairs. Senior Director requires a minimum of 10 years experience in regulatory affairs.
● Oncology and biologic/cell therapy experience is highly preferred.

● Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience working with FDA.

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Director of Global Regulatory CMC - MD

Regulatory Connect has partnered with a clincal stage Biopharma who have a very strong early stage development portfolio of Oncology products.

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 with FDA is essential and global experience is highly preferred.

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