Director, Regulatory Affairs Strategy

The Director Regulatory Affairs Strategy will be responsible for developing and implementing global regulatory strategy leading to successful registration and life-cycle management of unique products for patients with hematological, pulmonary/cardiovascular, and obesity/neuromuscular disorders with high unmet medical need. This individual will provide regulatory leadership to cross-functional teams responsible for global programs and ensure effective communication with business partners and representatives of the US Food and Drug Administration/EMA and other Health Authorities worldwide.

This person will work closely with cross-functional teams and subject matter experts to lead development and finalization of study-related regulatory documents, manage various routine regulatory submissions, lead preparation and related submissions for meetings with various Health Authorities as well as ensure compliance with safety and periodic reporting requirements for investigational drugs.

Primary Responsibilities:

• Provide regulatory strategic leadership for drug development projects, including but not limited, to health authority interactions, regulatory submissions, and other regulatory requirements in line with corporate objectives and timelines
• Serve as an influential and well-respected spokesperson with staff at FDA/EMA and other Health Authorities, including leading meetings and preparations to facilitate expedited approval of original applications and supplements
• Provide de-risking development strategies and evaluating opportunities to accelerate development
• Provide leadership and contribute hands on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA/EMA and other Health Authorities in support of INDs, CTAs, IMPDs, PIPs, BLAs, MAAs as well as Fast Track, Breakthrough, ODD, amendments, safety reports, and annual updates, as applicable
• Interpret and communicate regulatory expectations to internal and external stakeholders to execute program objectives in compliance with applicable regulations
• Contribute to the strategic leadership and development of policies, procedures, and best practices commensurate with the requirements of a rapidly growing company
• Participate in regulatory intelligence activities, monitor advisory committees, regulatory guidelines and trends.
• Ensure adherence to all relevant regulatory requirements, including FDA regulations, ICH guidelines, and local regulatory requirements.

Qualifications:

• Requires a MS degree (PharmD, or PhD preferred) with a minimum of 10 years of experience in the biotech/pharmaceutical industry, with a minimum of 8 years of experience within regulatory affairs
• Strong knowledge of FDA and EU regulations
• Prior experience with FDA and EMA, and success with filing INDs/CTAs/BLAs/NDAs/MAAs.
• Experience with both early and late-stage drug development
• Comfortable with setting strategies as well as taking a hands-on approach to all regulatory activities
• Experience required with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, briefing packages, PIPs and documents for other regulatory submissions
• Experience interacting directly with the FDA/EMA and other health authorities
• Strong leadership and communication skills and experience in working with multiple functional areas in a matrixed team environment required
• Strategic thinker who can balance near term objectives with long term goals and outcomes
• Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience
• Experience with biologics drug development is desirable
• Familiar with eCTD, e-publishing systems for preparing regulatory submissions a plus
• Ability to thrive in a collaborative and fast-paced team environment
• Ability to be in the office 3 days a week

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