Regulatory Affairs Manager
Accentuate Staffing is partnering with a leading biopharmaceutical company who is hiring for a Regulatory Affairs Manager to join their team. This is a direct hire opportunity, offering competitive compensation, bonus and benefits, while working onsite. The ideal candidate has strong regulatory expertise in biologics, experience managing cross-functional teams, and a proven track record of delivering high-quality regulatory submissions.
Responsibilities:
- Oversee and manage all Regulatory Affairs activities, ensuring accuracy, quality, and compliance of submissions to FDA, Health Canada, USDA, and other agencies.
- Lead preparation, submission, and management of regulatory filings such as INDs, BLAs, and 510(k)s.
- Provide regulatory strategy guidance to project teams and cross-functional departments to support product development and lifecycle management.
- Review and approve product labeling, promotional materials, and advertising to ensure regulatory compliance.
- Act as primary liaison with regulatory authorities and manage regulatory databases and submission tracking systems.
- Lead, mentor, and develop the regulatory team to ensure high performance, professional growth, and alignment with company objectives.
Requirements:
- Bachelor’s degree in a scientific discipline or equivalent; 5+ years of regulatory management experience in biologics or medical devices.
- Regulatory Affairs Certification (RAC) is required combined with a strong knowledge of US FDA, Health Canada, USDA, and ICH regulations.
- Proven experience managing eCTD submissions and regulatory filings for biologics.
- Strong leadership and team management skills with experience mentoring high-performing teams.
- Ability to interpret complex regulatory requirements and provide clear guidance to cross-functional teams.
- Excellent verbal and written communication skills, including preparation of SOPs, regulatory reports, and technical documentation.
