Job Description
Are you a detail-oriented professional passionate about shaping the future of healthcare? Vertex BioSciences is seeking a highly skilled Senior Regulatory Affairs Specialist to join our dynamic regulatory team in Cambridge, MA. In this pivotal role, you will oversee the submission and approval processes for our innovative drug candidates, ensuring full compliance with FDA and international regulatory standards.
As a leader in biotechnology, we are committed to excellence. We are looking for a strategic thinker who can navigate complex regulatory landscapes while collaborating cross-functionally with R&D, Clinical Operations, and Quality Assurance departments.
Responsibilities
- Submission Management: Lead the preparation, review, and submission of regulatory documents including IND, NDA, BLA, and DMFs to the FDA and EMA.
- Regulatory Strategy: Develop and implement regulatory strategies to optimize product lifecycles and market access for our therapeutic portfolio.
- Compliance Monitoring: Monitor changes in global regulations and ensure internal processes align with current Good Manufacturing Practices (cGMP) and Good Clinical Practices (GCP).
- Liaison: Act as the primary point of contact with regulatory authorities, managing inquiries and maintaining a proactive relationship.
- Project Leadership: Manage cross-functional project teams to meet critical regulatory milestones and timelines.
- eCTD Expertise: Oversee the electronic Common Technical Document (eCTD) submission process and ensure data integrity.
Qualifications
- Education: Bachelor’s degree in Pharmacy, Biology, Chemistry, or a related scientific field required; Master’s degree preferred.
- Experience: 5+ years of progressive experience in pharmaceutical regulatory affairs, with a focus on submissions and US FDA regulations.
- Technical Skills: Proficient in electronic submission tools (e.g., Veeva Vault, TrackWise) and eCTD software.
- Knowledge: Deep understanding of FDA 21 CFR Parts 312 and 314, and ICH guidelines.
- Communication: Exceptional written and verbal communication skills with the ability to translate complex scientific data into clear regulatory narratives.
- Soft Skills: Strong analytical problem-solving abilities and the capacity to work in a fast-paced, deadline-driven environment.