Senior Manager / Associate Director of Regulatory Affairs
Department: Regulatory Affairs
Job Title: Senior Manager / Associate Director of Regulatory Affairs
Report to: Senior Director of Regulatory Affairs
Location: US (Can be remote)
MAIN REPONSIBILITIES:
- Provide hands-on support across all aspects of regulatory affairs related to the development of novel therapeutics including nonclinical, clinical, quality, implementation of policies and procedures required to ensure compliance.
- Coordinate the preparation of eCTD submission ready documents and other assigned tasks within established timelines and with high quality in terms of content, organization, accuracy, format, consistency, and adherence to regulatory guidelines, styles, and processes.
- Manage the submission of INDs, CTAs, briefing packages, responses, and other submissions including supporting planned major submissions such as NDA. Routine lifecycle submissions such as annual reporting, safety submissions and correspondences.
- Support development program projects as assigned in collaboration with line manager and work with multi-disciplinary project teams to support successful development program deliverables.
- Support the regulatory team in developing and executing key regulatory initiatives and ensure routine regulatory submissions and processes are compliant with current regulations and guidance.
- Responsible for tracking and reporting of submission activities along with managing the processes for archiving correspondence and submissions.
- Supports the regulatory team planning and monitoring regulatory activities and other duties as assigned based on company needs, such as drafting SOPs and identification of best practices, researching regulatory precedent, competitive intelligence, GXP guidelines and health authority audit preparation.
QUALIFICATIONS:
- B.A/B.S in the sciences or health related field.
- Minimum of 5 years prior experience in the pharmaceutical industry in a regulatory affairs role.
- Proven track record of successful regulatory submissions and relationships with regulatory teams.
- Working knowledge of drug development process and regulatory requirements, guidelines, policies, and regulations of health authorities such as FDA and EMA.
- Ability to collaborate with other team members within global teams across multiple time zones.
