Job Description
Are you a seasoned Regulatory Affairs professional passionate about bringing life-changing therapies to patients faster? Veridian BioPharma Inc., a cutting-edge leader in innovative drug development, is actively seeking a highly motivated and experienced Senior Regulatory Affairs Specialist to join our dynamic team in Boston, MA. We are at the forefront of pharmaceutical innovation, dedicated to solving complex health challenges through scientific excellence and strategic regulatory compliance.
In this pivotal role, you will be instrumental in navigating the intricate global regulatory landscape, ensuring our groundbreaking products meet all necessary requirements for approval and market entry. You will leverage your expertise to develop robust regulatory strategies, prepare high-quality submissions, and collaborate cross-functionally to accelerate our mission. If you thrive in a fast-paced environment, possess exceptional analytical skills, and are ready to make a significant impact on patient lives, we invite you to apply.
Veridian BioPharma offers a vibrant culture of collaboration, continuous learning, and a commitment to employee growth. Join us and be a part of a team that is redefining the future of medicine!
Responsibilities
- Develop, implement, and maintain comprehensive regulatory strategies for assigned pharmaceutical products throughout their lifecycle.
- Prepare and submit high-quality regulatory documents to health authorities (e.g., FDA, EMA, Health Canada), including INDs, NDAs, BLAs, MAAs, amendments, and supplements.
- Serve as a primary liaison with regulatory agencies, facilitating effective communication and negotiation during submissions and reviews.
- Collaborate cross-functionally with R&D, Clinical, Quality, and Manufacturing teams to ensure regulatory compliance and align on submission timelines.
- Interpret complex regulatory guidelines and provide strategic advice to internal teams on compliance requirements, risk assessments, and emerging regulations.
- Review and approve manufacturing, quality control, and clinical documents for regulatory consistency and accuracy.
- Support the planning and execution of regulatory inspections and audits.
- Maintain current knowledge of global regulatory requirements and industry best practices, disseminating updates to relevant stakeholders.
Qualifications
- Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology) required; Master's or PhD preferred.
- 5+ years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Demonstrated experience in preparing and submitting major regulatory applications (INDs, NDAs, BLAs, MAAs).
- In-depth knowledge of FDA regulations (e.g., 21 CFR), ICH guidelines, and global regulatory requirements.
- Proven ability to interpret complex scientific data and translate it into clear, concise regulatory submissions.
- Excellent written and verbal communication skills with the ability to articulate complex regulatory concepts to diverse audiences.
- Strong project management skills with the ability to manage multiple priorities in a deadline-driven environment.
- RAC certification is a plus.