Job Description
Elevate Your Career with AstraGen Biotherapeutics
At AstraGen, we are pushing the boundaries of science to deliver life-changing medicines. We are looking for a high-caliber Senior Regulatory Affairs Specialist to join our elite team in Cambridge. This role is pivotal in navigating the complex landscape of global drug development, ensuring our innovative therapies reach the patients who need them most.
As a key strategic partner, you will influence the lifecycle of our pipeline products, from early-stage clinical trials to commercialization. If you are a regulatory professional with a passion for excellence and a drive for innovation, AstraGen offers the platform to make a global impact.
Responsibilities
- Lead the strategic planning, preparation, and submission of IND, NDA, and BLA applications to the FDA and global health authorities.
- Serve as the primary point of contact for regulatory agency interactions, including leading preparation for formal meetings and briefings.
- Provide expert regulatory guidance to cross-functional teams on CMC, clinical, and non-clinical development strategies.
- Monitor and interpret the evolving regulatory landscape to assess impact on project timelines and risk mitigation plans.
- Ensure 100% compliance with GxP standards and internal quality management systems across all regulatory dossiers.
- Collaborate with international partners to harmonize global labeling and registration strategies for multi-market launches.
Qualifications
- Advanced degree (MS, PhD, or PharmD) in Life Sciences, Chemistry, or a related pharmaceutical field.
- Minimum of 7-10 years of direct Regulatory Affairs experience in the pharmaceutical or biotech industry.
- Proven track record of successful FDA submissions and hands-on experience with eCTD requirements.
- Exceptional project management skills with the ability to lead high-stakes, deadline-driven initiatives.
- Strong analytical mindset with the ability to translate complex scientific data into persuasive regulatory narratives.
- RAC (Regulatory Affairs Certification) is highly preferred but not mandatory.