This clinical-stage biotechnology company is developing treatments for complex rare diseases. They are seeking a Regulatory Affairs Associate Director or Director to support global regulatory strategies and regulatory activities for products in development. You will be a key member of project teams, working closely with other departments and outside consultants. This company offers a patient-focused culture and the ability to work remotely. With their lead program currently in Phase 2 trials, now is an exciting time to join this growing company!
- Contribute to development and execution of global regulatory strategies for rare disease programs in development.
- Plan, author and review high quality regulatory submissions (INDs, CTAs, Health Authority Meeting Packages, BLA). Manage preparation and submission including development of timelines.
- Interface with cross-functional teams and outside consultants to obtain timely regulatory deliverables and ensure regulatory compliance.
- Advise other departments on global regulatory health authority requirements for product development and regulatory submissions.
- Participate in negotiations with regulatory agencies to resolve issues, and prepare and submit responses to questions. Prepare for Health Authority meetings including briefing books, etc.
- May serve as back up to Regulatory Operations for filing global regulatory submissions.
- Maintain ongoing awareness of global regulations and guidelines relevant to projects.
- Develop internal regulatory procedures and practices
- Bachelor degree in life sciences required. Advanced degree (MS, PharmD, or PhD preferred)
- At least eight years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologic therapeutics.
- Experience with rare/orphan drugs preferred but not required. Some experience with biologics a plus.
- Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to INDs, IND amendments, CTA submissions, Health Authority Meeting packages, and marketing authorization applications (NDA, BLA or MAA).
- Experience interacting with Health Authorities including meeting preparation.
- Knowledgeable in ICH, FDA and EMA guidelines. Understanding of GxP systems and Quality principles.
- Ex-US and/or global regulatory experience highly desired.
- Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies.
- Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions.
- Excellent communication, time management and project management skills.
- Continuous quality improvement mindset and attention to details.
- Can do attitude, flexibility, and mental agility.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment