Our client a Global Pharmaceutical Company have opened a new vacancy and are looking to recruit a Regulatory Affairs Consultant on an initial 6 month contract based at Walton Oaks (once office re-opens).
In line with defined product responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.
- Provide regulatory input to commercial strategic and operating planning process.
- Manage and Submit Marketing Authorisation Applications & MA Variation/Renewal Applications.
- Manage Clinical Trial Approvals (if performed in country)
- Attend relevant product team meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary. Ensure teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities.
- Build personal expertise through management of specified products within one or more therapy areas.
- Facilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate.
- Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions.
- Work with above country regulatory strategists (AC-RS) to provide country input into Global and European Regulatory Strategies as required.
- Use expert knowledge of EU/national legislation, guidelines, regulatory environment to provide insightful responses to enquiries from cross-divisional colleagues and direct or indirect interactions with external customers.
- Advise on matters of compliance, regulatory requirements and regulatory policy.
- Partner with above-country operational hubs to prepare and collate information needed for contribution to departmental and ad hoc reports.
- Management of Safety Reports and Issues with Regulatory Authorities
- Life sciences or chemistry graduate to honours level or equivalent
- Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products) & Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred
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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