Role is to develop and implement regulatory strategy for registration and reimbursement of new products, in close collaboration with relevant and taking into account business strategy and regulatory requirements
Key duties will include
- Product registration, and reimbursement, launch and maintenance
- Development of regulatory strategies for registration approval including novel ingredients as per business needs (assessment of formulas, advice on product category, handle tactics and submission timing, verification of label claims, setting mitigation plans, etc.)
- Negotiate with regulatory authorities during the review process to ensure registration and reimbursement approval
- Provide regulatory support to commercial division in all areas pertaining to product life-cycle management and new product development and introduction
- Effectively participate in NPI project teams and ensure timely completion of tasks and clear communication of regulatory risks and opportunities
- Ensure implementation of new regulations/guidance within legal deadlines
- Approval of labels, advertising and promo materials ensuring alignment with local regulations, Codes of Conduct, SOPs, etc
- Product development and support to develop most rapid successful strategy for approval to market products to meet business objectives
- Individual is recognized as an industry expert and resource in regulatory affairs.
- Provides technical leadership to business units
The successful candidate will have
- Bachelor's degree (or equivalent) in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology, etc.)
- 3 years experience in a regulated industry (e.g., medical products, nutritionals).
- 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Excellent written English and communication skills
- Highly developed project management skills
For more information please contact Clodagh D’Arcy on 0873470221 or email details to Clodagh.email@example.com