Our client a Global Pharmaceutical Company have opened a new vacancy within there Regulatory team and are looking to recruit a Regulatory Senior Manager on a 12-month contracts based in Brentford after COVID.
The purpose of this role is to provide regulatory leadership, governance and expertise to one category, sub-category, brand or a portfolio of products such that our products are successfully introduced or maintained Globally. The individual will build a network of collaborative relationships within the sub-category and LOC/Region and ensure all regulatory requirements are met for both innovation and existing products.
- Act as a Business Partner and provide regulatory advice across sub-Category / significant portfolio on all aspects of drug / cosmetic / devices / foods and supplements (dependent on category) development and regulatory requirements, both current and future.
- Provide regulatory path to market / claims for a sub-category / significant portfolio of products.
- Develop novel regulatory strategies and influences approaches in order to secure competitive approvals and speed to market in conjunction with LOC/Region regulatory teams.
- Communicate, influence and negotiate effectively with cross-functional internal and external groups at all levels.
- Ensure appropriate prioritization and resourcing of projects and delivery of high-quality regulatory files to agreed timelines
- Lead non-product related activities, both in the function and cross functionally, in order to direct new policy or pioneer new processes or improvements to the company's competitive advantage.
- Influence the external regulatory environment through networking with key individuals, identifying opportunities and influencing guidelines. May act as internal representative to external groups for specific topics (e.g. national or pan-national trade associations)
- Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within the CAP meetings and tools.
In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc. with supply chain and technical excellence Oversees compliance in all actions by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.
- Life sciences degree and relevant experience or PhD or equivalent relevant experience.
- Experience with Medicinal Products is a must
- Global Regulatory experience is required to be successful
- Ideally 8-10 years' experience as a senior manager
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or +441753 589673
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