What are the responsibilities and job description for the Manager Regulatory Affairs position at Search Solution Group?
Job Overview :
Search Solution Group is seeking a Manager of Regulatory Affairs on behalf of our client, a biopharmaceutical company specializing in allergen immunotherapy for the diagnosis and treatment of allergies. This role is critical in overseeing and managing all regulatory activities to ensure compliance with FDA, Health Canada, USDA, and other global regulatory agency requirements. The Manager of Regulatory Affairs will play a pivotal role in supporting product development, lifecycle management, and ensuring timely regulatory submissions.
Key Responsibilities :
- Oversee and manage the preparation, submission, and tracking of regulatory filings such as INDs, BLAs, and 510(k)s.
- Lead communication with regulatory agencies, including formal meetings, teleconferences, and written responses.
- Ensure technical accuracy and compliance of all regulatory submissions in the appropriate format (eCTD).
- Oversee labeling and prescribing information for biologic and veterinary products.
- Review and approve promotional materials to ensure adherence to regulatory guidelines.
- Provide regulatory strategy guidance to support product development and lifecycle management.
- Act as the primary liaison between the company and regulatory authorities, including FDA, Health Canada, and USDA.
- Collaborate across departments (Quality, R&D, Manufacturing, and Commercial) to address complaints and investigations.
- Monitor and assess regulatory changes, recommending necessary actions for compliance.
- Aggregate and submit safety reports, including PAERs, PBRERs, and ASRs.
- Manage regulatory databases and tracking systems for submissions and approvals.
- Lead and mentor the regulatory team, fostering professional growth and high performance.
- Develop and implement SOPs to maintain compliance and improve operational efficiencies.
- Plan and manage the Regulatory Affairs budget, ensuring alignment with company objectives.
Requirements Include :
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How to Apply :
To apply for this position, please click the "Apply" button at the top right of your screen. Alternatively, you can email your resume and relevant documents to info@ssgresume.com . We look forward to reviewing your application.
Company Overview :
Industry : Biopharmaceuticals
Location : Flexible, based on operational needs
Equal Opportunity Employer Statement :
Search Solution Group is an Equal Opportunity Employer committed to fostering an inclusive workplace where diversity is valued and respected. Employment decisions are based on qualifications, merit, and business needs.
Disclaimer :
This job description is not exhaustive and may be subject to change. Additional duties may be assigned as needed to meet the organization's evolving needs.
