Job Description
Apex Pharma Solutions is a global leader in biopharmaceutical innovation, dedicated to advancing healthcare through cutting-edge research and development. We are currently seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to join our dynamic team in the heart of Boston, Massachusetts.
In this pivotal role, you will be responsible for navigating the complex landscape of global regulatory compliance. You will lead the preparation and submission of critical regulatory dossiers, ensuring our products meet the highest standards of safety and efficacy. If you are a strategic thinker with a passion for healthcare policy and a desire to make a tangible impact on patient lives, we want to hear from you.
Why join us?
• Competitive salary and comprehensive benefits package.
• Opportunities for professional growth in a world-class facility.
• Collaborative environment with industry-leading experts.
Responsibilities
- Oversee the preparation and submission of regulatory dossiers (MAA, NDA, BLA) to global health authorities (FDA, EMA, PMDA).
- Manage the regulatory lifecycle of product candidates, ensuring continuous compliance with local and international guidelines.
- Liaise effectively with cross-functional teams including R&D, Clinical Operations, Quality Assurance, and Legal.
- Lead regulatory strategy sessions and present complex data to executive leadership.
- Conduct internal training and mentorship for junior regulatory affairs associates.
- Monitor regulatory trends and propose strategic adjustments to product development roadmaps.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 5 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology sector.
- Deep understanding of FDA 21 CFR Part 11, ICH guidelines, and EMA regulations.
- Strong project management skills with the ability to prioritize multiple deadlines in a fast-paced environment.
- Excellent written and verbal communication skills in English.
- Proficiency in regulatory submission software (e.g., Veeva Vault, MasterControl).