Director - Regulatory Affairs Strategy

June 22

Apply Now

Receive Emails with Similar Jobs

Immunovant

WebsiteLinkedInAll Job Openings

Dedicated to enabling normal lives for people with autoimmune diseases

Biotechnology Research

51 - 200

Description

• This highly dynamic team is seeking an entrepreneurial and strategic Director, Regulatory to play a key role on our cross-functional R&D team. In this role, you will be responsible for leading and contributing the drug development into innovative global regulatory strategies that expedite development, maximize the probability of success, identify regulatory opportunities, and mitigate risks. The individual in this position will have the unique opportunity to grow and mentor regulatory scientists on regulatory requirements and regulatory environmental trends, as well as help shape the regulatory approach in a rapid-growth biotech startup.

Requirements

• 10+ years of biopharmaceutical experience, which includes at least 8 years of direct experience in Regulatory Affairs. • An advanced degree (Master’s or PhD) in a relevant scientific discipline is preferred. • Experience in biologics drug development and parenteral products, including combination products and orphan/rare disease product development. • Experience in developing 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 leading multiple interactions with the FDA and other global regulatory authorities. • Strategic and analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. • Ability to problem-solve development hurdles and apply learnings. • Works collaboratively and efficiently with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, external vendors, and contract organizations. • Strong team and project management skills. • Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences, including executive leadership. • Ability to thrive in a collaborative and fast-paced environment. • Results-oriented individuals with a strong work ethic and ability to complete projects with minimal oversight. • Knowledge of GxP, ICH, FDA, EMA and other global regulations and guidances. • Attention-to-detail and an ability to balance analytical and critical-thinking skills to develop data-driven, strategically oriented regulatory proposals and documents. • Experience developing 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. • Strong oral and written communicator. • 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. • Skilled in developing collaborative internal and external relationships. • 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, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.