Senior Regulatory Affairs Specialist

• Develops and implements programs and processes to ensure that company products are safe legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
• Regulatory support for integration activities including reviews of product labeling and marketing materials for accuracy and compliance with regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies as required.
• Compiles materials required in submissions license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
• Proactively manages the changing regulatory environment for company products prevents barriers to trade eliminates duplication of effort and identifies and mitigates areas of risk.
• Responds to customers and/or authorities requests/inquiries dealing with regulations and product compliance.
• Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level.

The Ideal Candidate will have:

• Bachelors or masters Degree or equivalent.
• Regulatory experience in a highly regulated industry such as pharmaceuticals or diagnostics
• Typically at least 4 years relevant experience for entry into this level.
• Post-graduate certification and/or license may be required.