Job Description
Are you a detail-oriented professional passionate about bringing life-changing therapies to market?
BioPharma Solutions is seeking a highly skilled Regulatory Affairs Specialist to join our dynamic team in San Francisco. In this pivotal role, you will ensure our innovative drug development programs meet all local and international regulatory standards, driving the company's mission to improve global health outcomes.
We offer a collaborative environment, competitive compensation, and the opportunity to work on cutting-edge pharmaceutical projects that truly matter.
Responsibilities
- Manage Regulatory Submissions: Lead the preparation and submission of regulatory documents (INDs, NDAs, MAAs) to FDA and EMA authorities.
- Compliance Monitoring: Stay abreast of global regulatory changes and implement necessary updates to company policies and procedures.
- Liaison Management: Act as the primary point of contact for regulatory agencies and cross-functional teams (R&D, Quality Assurance, Clinical Operations).
- Documentation Control: Maintain accurate, up-to-date regulatory libraries and ensure full traceability of all submission records.
- Strategic Planning: Assist in the development of regulatory strategies to accelerate product timelines and market access.
Qualifications
- Education: Bachelor’s degree in Pharmacy, Biology, Chemistry, or a related Life Sciences field (Master’s degree preferred).
- Experience: Minimum of 3-5 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Technical Skills: In-depth knowledge of FDA 21 CFR Part 11, EMA guidelines, and ICH guidelines.
- Communication: Exceptional written and verbal communication skills with the ability to translate complex technical data into clear regulatory narratives.
- Attention to Detail: Proven track record of managing complex documentation with zero errors.