Job Description

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:

1. Oversee and manage all Regulatory Affairs activities, ensuring accuracy, quality, and compliance of submissions to FDA, Health Canada, USDA, and other agencies.
2. Lead preparation, submission, and management of regulatory filings such as INDs, BLAs, and 510(k)s.
3. Provide regulatory strategy guidance to project teams and cross-functional departments to support product development and lifecycle management.
4. Review and approve product labeling, promotional materials, and advertising to ensure regulatory compliance.
5. Act as primary liaison with regulatory authorities and manage regulatory databases and submission tracking systems.
6. Lead, mentor, and develop the regulatory team to ensure high performance, professional growth, and alignment with company objectives.

Requirements:

1. Bachelor’s degree in a scientific discipline or equivalent; 5+ years of regulatory management experience in biologics or medical devices.
2. Regulatory Affairs Certification (RAC) is required combined with a strong knowledge of US FDA, Health Canada, USDA, and ICH regulations.
3. Proven experience managing eCTD submissions and regulatory filings for biologics.
4. Strong leadership and team management skills with experience mentoring high-performing teams.
5. Ability to interpret complex regulatory requirements and provide clear guidance to cross-functional teams.
6. Excellent verbal and written communication skills, including preparation of SOPs, regulatory reports, and technical documentation.

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