Regulatory Affairs Strategy Lead
1 dzień temu
**About the Role**
We are seeking a highly skilled and experienced Senior Manager Regulatory Affairs to join our team at Randstad Polska Sp. z o.o. As a key member of our regulatory affairs department, you will be responsible for leading the development and execution of global CMC regulatory strategies. Your expertise will ensure compliance with regulatory requirements and facilitate successful product development globally.
Key Responsibilities
- Participate as the Regulatory CMC Lead on CMC/VST Teams and represent Global CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations.
- Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements and commitments.
- Develop and execute global CMC regulatory strategy.
- Lead the preparation of regulatory dossiers for submission to Health Authorities.
- Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed.
- May lead selected initiatives within CMC RA / GRA
- Participate in and conduct due diligence/licensing evaluations as needed
- May provide oversight of assigned staff.
- Drive a culture of continuous improvement and communicates critical issues to Management.
- May represent CMC RA on Cross Functional Teams
- May serve as a SPOC/SME on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise.
- Ensure the CMC development and commercial product regulatory strategy meets global regulatory requirements.
- Assure connectivity to the overall global regulatory strategy through partnership and communication other departments.
- Refine regulatory strategies as new data become available.
- Develop and update contingency plans for issues that may affect registration, regulatory compliance and the continued lifecycle management of the products in scope.
- Effectively and tactfully communicate with health authorities.
- Reviews CMC regulatory dossiers for global submissions throughout the product lifecycle
- Provides accurate regulatory assessments of chemistry, manufacturing and control changes to teams/projects and executes regulatory planning and implementation.
About You
- BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 10+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent.
- Proficiency in English (min. C1).
- Demonstrated ability to communicate regulatory requirements.
- Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
- Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy.
- Strong attention to detail with high-level verbal and written communication skills
- Communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project teams.
- Demonstrates model behavior that understands what the priorities are and encourages others to drive for results
- Experience leading interactions with Health Authorities under supervision of a senior member of the CMC RA staff.
- Strong knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.
- Good understanding of competitors in the area and what they are doing in early/late development.
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