Job Overview:
A global biopharmaceutical company is seeking an experienced Regulatory Affairs Manager to oversee and manage regulatory activities for its operations in the Americas. The role involves ensuring compliance with relevant regulatory authorities such as the US FDA, Health Canada, and the USDA, while also contributing to regulatory strategy and product lifecycle management.
Key Responsibilities:
- Lead and manage all regulatory submissions, ensuring compliance with agencies like the FDA, Health Canada, and USDA.
- Oversee the preparation and submission of filings, including INDs, BLAs, 510(k)s, and other applications for both new and existing products.
- Manage product and manufacturing changes, ensuring regulatory compliance throughout.
- Plan and participate in meetings with regulatory bodies, responding to requests in a timely manner.
- Ensure all product labeling, promotional materials, and advertising comply with regulatory requirements.
- Provide regulatory guidance to cross-functional teams on product development and lifecycle management.
- Act as the primary liaison with regulatory agencies.
- Collaborate with internal departments (Quality, R&D, Manufacturing) to address regulatory concerns related to product complaints or investigations.
- Maintain accurate product registration and drug listings in accordance with global regulations.
- Track and monitor changes in regulatory policies and assess their impact on company products.
- Oversee the compilation of safety reports such as PAERs, PBRERs, and ASRs.
- Assist in the planning and management of the regulatory affairs budget.
- Lead, mentor, and develop the regulatory team to ensure continued professional growth and alignment with company goals.
Job Requirements:
- Bachelor’s degree in a scientific discipline (or equivalent); advanced degree preferred.
- Minimum of 5 years of experience in regulatory management, particularly within biologics or medical devices.
- Familiarity with US FDA, Health Canada, and USDA regulations, and eCTD submission formats.
- Proven ability to interpret complex regulatory requirements and provide clear guidance to internal stakeholders.
- Strong leadership and communication skills, with the ability to inspire and motivate teams.
- Regulatory Affairs Certification (RAC) preferred.
Key Performance Indicators:
- Timely and cost-effective delivery of regulatory strategies.
- On-time submissions to regulatory bodies.
- High-quality reporting to enable decision-making and issue resolution.
Additional Details:
- Direct reports: Yes
- Financial responsibility: Involved in managing the regulatory affairs budget.
- Travel: Infrequent travel may be required.
- Languages: Fluent English (spoken and written).
The company offers a competitive compensation package, including base salary, bonuses, and comprehensive benefits.
