Associate Director, Regulatory Affairs Strategy

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in developing and implementing regulatory strategies that accelerate project advancement and enhance the likelihood of success.

• Aid in reducing identified regulatory risks.

• Comprehend international regulatory requirements to support strategic initiatives.

• Collaborate to ensure project teams fully grasp the regulatory strategy.

• Organize, prepare, and coordinate regulatory documents for submissions to global health authorities, including INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.

• Work with both internal and external cross-functional team members to facilitate submissions and secure timely application approvals.

• Assist in interactions with the FDA and other Health Authorities.

• Develop communications regarding project updates and risks for senior management and organizational stakeholders.

• Monitor regulatory commitments, deliverables, and overall project schedules.

• Keep abreast of current global regulatory requirements.

• Contribute to the development of policies and procedures that align with GxPs, international regulatory requirements, guidance, and corporate objectives.

• Provide direct support to cross-functional teams in the preparation and coordination of regulatory submission documents.

⛳️ Requirements

• Over 8 years of experience in the biopharmaceutical industry, with at least 4 years in direct Regulatory Affairs roles.

• Background in biologics or small-molecule drug development, parenteral products including combination products, and orphan/rare disease product development.

• Experience in implementing regulatory strategies within a global context.

• Extensive knowledge of applicable global regulations, guidance, and practices.

• Practical experience in preparing and submitting global regulatory documents, including IND/CTA, NDA/BLA/MAA, briefing documents, Clinical Trial Applications, and Agency queries.

• Proven experience in facilitating interactions with the FDA and other global regulatory bodies.

• Strong problem-solving capabilities and adaptability to evolving priorities and timelines.

• Skillful in addressing regulatory challenges and applying lessons learned.

• Ability to work collaboratively and effectively across various functional areas in a dynamic, matrixed environment, including management, functional teams, external vendors, and contract organizations.

• Exceptional team and project management skills.

• Excellent verbal and written communication abilities.

• Results-driven with a strong work ethic, capable of completing projects with oversight.

• Familiarity with GxP, ICH, FDA, EMA, and other global regulations and guidance.

• Keen attention to detail; strong analytical and critical-thinking skills for data-driven regulatory proposals and documentation.

• Experience supporting regulatory strategies for biologics and/or rare disease development programs.

• Commitment to the company's values and culture.

• Ability to navigate change and uncertainty effectively.

• Self-driven, takes initiative, and follows through on assigned tasks.

• Capacity to multitask and reprioritize under tight deadlines.

• Proficient in PC usage and MS Office applications, including Outlook, Word, Excel, PowerPoint, and Project.

• Willingness to travel domestically or internationally 10–20% of the time.

• An advanced Master’s degree in a relevant scientific discipline is preferred but not mandatory.

🏝️ Benefits

• Equity and other forms of compensation may be included in the total compensation package.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• 401k plan.

• Unlimited paid time off.

• Parental leave.