Job Description
Are you a strategic leader ready to shape the future of healthcare? NexGen Biopharmaceuticals is seeking a highly skilled Senior Regulatory Affairs Manager to drive our global compliance and submission strategies. In this pivotal role, you will oversee the regulatory lifecycle of our innovative drug candidates, ensuring seamless navigation of complex FDA and EMA guidelines. Join a forward-thinking team dedicated to bringing life-changing therapies to patients worldwide.
Responsibilities
- Lead the preparation and submission of regulatory documents (DMRs, NDAs, BLAs) to the FDA and EMA.
- Develop and implement comprehensive regulatory strategies to support clinical trial progression and product commercialization.
- Monitor and interpret changes in global regulations to mitigate compliance risks and maintain market access.
- Liaise with cross-functional teams, including R&D, Clinical Operations, and Quality Assurance, to ensure regulatory requirements are integrated.
- Manage external relationships with regulatory consultants, law firms, and health authorities.
- Oversee the maintenance and organization of regulatory documentation and electronic submissions systems.
Qualifications
- Bachelor’s degree in Pharmacy, Biology, Chemistry, or a related Life Science field (Master’s degree preferred).
- Minimum of 5-7 years of progressive experience in pharmaceutical regulatory affairs, with a strong focus on US and EU submissions.
- Deep understanding of ICH guidelines, 21 CFR Parts 312 and 314, and EMA procedures.
- Proven track record of successfully managing regulatory submissions from IND to NDA/BLA stages.
- Excellent project management skills with the ability to prioritize multiple high-stakes deadlines.
- Strong written and verbal communication skills, with the ability to present complex regulatory concepts clearly.