Associate Director, Regulatory Affairs Strategy

August 23

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Immunovant

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Dedicated to enabling normal lives for people with autoimmune diseases

Biotechnology Research

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Description

• Support and contribute to regulatory strategies that expedite development and maximize the probability of success based on knowledge of regulatory environment • Help mitigate identified regulatory risks • Understand global regulatory requirements to support strategy • Collaborate to ensure regulatory strategy is understood by project teams • Play a hands-on role in planning, preparing, and coordinating regulatory documents for submission to global health authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries • Close collaboration with internal and external cross-functional team members to ensure the achievement of submissions and timely approvals of applications • Support interactions with FDA and other Health Authorities • Help formulate communications of project updates and risks to senior management and stakeholders across the organization • Track regulatory commitments, deliverables, and overall project timelines • Maintain up-to-date knowledge and understanding of global regulatory requirements • Contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives • Provide hands-on support to cross-functional teams in planning, preparing, and coordinating documents for submission to global authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries

Requirements

• 6+ years of biopharmaceutical experience, which includes at least 4 years of direct experience in Regulatory Affairs • An advanced degree (Master’s) in a relevant scientific discipline is preferred • Experience in biologics or small molecule drug development, parenteral products, including combination products, and orphan/rare disease product development • Experience in supporting and implementing regulatory strategies in a global environment • Comprehensive understanding of applicable global regulations, guidance, and practices • Demonstrated hands-on experience in the preparation and submission of global regulatory documents, including clinical trial applications and maintenance (IND/CTA), NDA/BLA/MAA, briefing documents, Clinical Trial Applications, and Agency queries • Prior experience in supporting interactions with FDA and other global regulatory authorities • Excellent problem-solving skills and the ability to adapt to changing priorities and deadlines • Ability to problem-solve regulatory issues and apply learnings • Works collaboratively and efficiently with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations • Strong team and project management skills • Strong verbal and written communication skills • Results-oriented individual with a strong work ethic and ability to complete projects with oversight • Knowledge of GxP, ICH, FDA, EMA, and other global regulations and guidance • Attention to detail and an ability to balance analytical and critical-thinking skills to support data-driven, strategically oriented regulatory proposals and documents • Experience supporting regulatory strategies for biologics and/or rare disease development programs • Commitment to company values and culture • Proven ability to adapt to change and uncertainty as projects evolve • Self-motivated, with initiative and the ability to take ownership of and follow through with specific tasks • Ability to multi-task and adjust priorities quickly while working under tight deadlines • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint, Project)

Benefits

• Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package • Full range of medical, dental, vision, 401k, and other benefits • Unlimited paid time off • Parental leave