Senior Medical Advisor Salary: competitive salary & benefits Job Type: PermanentLocation: Thames ValleyI am currently working with a Global Pharmaceutical Company who have a brand...
My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Senior Regulatory Affairs Consultant on an initial 12 Month basis to be based at their offices in Cambridgeshire or Middlesex
To ensure my client acquires and maintains all the required licenses in order to support clinical trials for investigation medicinal products as well as market commercially approved medicinal products. This role may provide management and leadership by supervising one or more other regional regulatory lead.
- Plans and manages regulatory submissions) for products within my clients portfolio in compliance with global filing plans and local regulatory requirements.
- Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)
- Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Leads development of regional regulatory documents and meetings in accordance with Global Regulatory strategy
- Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and PIPs)
- Directs the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Manages regional label negotiation activities evaluates and communicate impact of relevant regional regulations, guidance, current regulatory environment and competitor labelling.
- Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy-includes contingency regulatory planning/risk assessment
- Life Sciences Degree qualified.
- Extensive hands on Regulatory Affairs experience within a strategic capacity, including providing scientific advice and working in EU Centralised procedures,
- Expert within Development projects including PIP's
- Post Approval Regulatory- Variations and New Line Extensions
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Neal.Panting@SRG.co.uk or +441753 589626