Job Description
Join a world-class team at Apex Biopharma Solutions, where innovation meets compliance. We are seeking a visionary Senior Regulatory Affairs Specialist to lead our regulatory strategy and ensure the successful launch of next-generation therapeutics. In this pivotal role, you will navigate the complex landscape of global health regulations, bridging the gap between scientific discovery and regulatory approval.
As a leader in the pharmaceutical sector, we pride ourselves on our commitment to patient safety and product excellence. If you are a detail-oriented professional with a passion for healthcare policy, we want you to help shape the future of medicine.
Responsibilities
- Lead the preparation and submission of regulatory dossiers (IND, NDA, ANDA, BLA) to the FDA and international authorities.
- Oversee the entire lifecycle of regulatory submissions, including amendments, supplements, and responses to information requests.
- Conduct comprehensive regulatory landscape analysis to identify opportunities for market expansion and compliance optimization.
- Collaborate cross-functionally with R&D, Quality Assurance, and Clinical Operations to align product development with regulatory requirements.
- Maintain up-to-date knowledge of global pharmacopeias and regulatory guidelines, ensuring our portfolio remains compliant.
- Manage relationships with external regulatory consultants and external affairs teams to streamline approval processes.
Qualifications
- Master’s degree in Pharmacy, Biology, Chemistry, or a related Life Sciences field.
- Minimum of 5-7 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Deep understanding of FDA 21 CFR Part 11, EMA Guideline on Good Pharmacovigilance Practice (GVP), and ICH guidelines.
- Proven track record of successful regulatory submissions and approval pathways.
- Exceptional analytical, problem-solving, and communication skills.
- Strong project management abilities with the capacity to manage multiple high-priority deadlines.