This growing biopharmaceutical company is developing medicines for patients who suffer from serious, rare neurological diseases. They are seeking a Regulatory Affairs Associate Director or Director who can develop and execute global regulatory strategies for the company’s late-stage program. Reporting into the Regulatory Affairs Vice President, you will work directly with FDA and other health authorities, while helping to get transformative drugs approved. This company offers a patient-first culture, flexible PTO, and the ability to work remotely. With their lead program heading into Phase 3 trials, now is an exciting time to join this growing organization!
Responsibilities:
- Develop and execute global regulatory strategies for product development, approval, and registration for rare neurological disease programs.
- Lead and advise cross-functional teams on regulatory strategies that optimize and expedite the development and maximize the probability of success by mitigating anticipated risks.
- Maintain regulatory applications to ensure compliance with regulations, including the preparation, review, and execution of pre- and post-marketing submission deliverables.
- Serve as Regulatory lead or co-lead on assigned drug project teams, providing regulatory guidance and recommendations that are in line with the company goals, international laws, and regulations, including but not limited to:
- Phase 3 development activities
- Health authority meetings related to drug development and marketing applications
- Lead and/or support strategy and execution: amendments/supplements and other policies and procedures as assigned
- Work with Regulatory Affairs leadership to review and approve promotional and non-promotional materials.
- Conduct frequent Regulatory Intelligence related to the assigned programs and disseminate relevant information to Sr. Management and cross-functional teams.
- When applicable, mentor and direct junior-level regulatory personnel, who may or may not report directly to the incumbent.
- Manage other regulatory activities as assigned, which may involve nonclinical studies and strategies, and commercial activities.
Qualifications:
- Advanced degree such as PharmD, MD, or PhD preferred
- 8-10 years of Regulatory Affairs experience in the biopharmaceutical industry
- Rare Disease experience is required; late-stage development experience for rare diseases is preferable
- Experience with successful US and EU submissions in rare disease
- Experience leading, preparing, and submitting successful submissions, preferably NDAs and MAAs.
- Ability to analyze and interpret scientific data and regulations to apply to a rare disease program
- Evidence of being a critical strategic thinker who is solution-oriented with the ability to think outside of the box.
- Ability to prioritize multiple urgent priorities and experience with wearing multiple hats; management also of non-regulatory functional activities is preferred
- Thorough understanding and demonstrated experience with eCTD submission requirements, utilizing document templates, and knowledge of global operational regulations and guidelines
- Excellent written and oral communication skills
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.