Job Description
Are you a strategic thinker ready to shape the future of medicine?
Apex Biopharma Solutions is seeking a highly skilled Senior Regulatory Affairs Specialist to join our dynamic team in Boston, Massachusetts. In this pivotal role, you will drive the regulatory strategy for our pipeline of innovative therapeutics, ensuring compliance with global health authority standards while accelerating time-to-market.
We are looking for a leader who thrives in a fast-paced environment, possesses a deep understanding of FDA and EMA regulations, and can collaborate seamlessly with cross-functional R&D and Clinical Operations teams. If you are passionate about bringing life-changing drugs to patients, this is your opportunity to make a significant impact.
Responsibilities
- Lead Regulatory Strategy: Spearhead the preparation, review, and submission of complex regulatory documents including INDs, NDAs, and MAAs to the FDA and EMA.
- Compliance Management: Monitor changes in global regulatory policies and ensure the organization maintains full compliance with 21 CFR Part 11 and GxP standards.
- Submission Management: Oversee the regulatory lifecycle of products, managing timelines and coordinating with vendors to ensure timely approvals.
- Documentation Control: Maintain a robust regulatory filing system, ensuring all documentation is accurate, up-to-date, and easily accessible for audits.
- Cross-Functional Collaboration: Work closely with Clinical Development, Quality Assurance, and Manufacturing teams to resolve regulatory issues and facilitate smooth transition phases.
- Audit Preparation: Act as the primary point of contact for regulatory audits and inspections, preparing the necessary responses and evidence.
Qualifications
- Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related field; Master’s degree preferred.
- Experience: Minimum of 5-7 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Certification: RAC (Registered Associate of the RAPS) certification is highly desirable.
- Technical Skills: In-depth knowledge of FDA regulations (21 CFR Part 312, Part 21) and EMA guidelines.
- Communication: Exceptional written and verbal communication skills with the ability to negotiate effectively with regulators.
- Organizational Skills: Proven ability to manage multiple priorities and deadlines in a highly regulated environment.