Regulatory Senior Manager

Job Ref: J33841
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 18 October 2019
  • Berkshire, England, UK Berkshire Berkshire UK SL6 4UB
  • Competitive
    HOUR
  • Natasha Rollason
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My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Senior Manager to be based in their offices in Berkshire on a 12 month contract.

The Role:

To be responsible for delivering clinical development regulatory strategies & operations for a designated portfolio of high profile development compounds globally.

Key Responsibilities:

  • Manage a portfolio of complex Clinical Trial Applications and provide strategic global regulatory advice enabling efficient study start up and reducing potential issues impacting development timelines.
      • Represent CTRG in clinical study and programme planning meetings, provide innovative insights and best practices, as well as strategic and operational support
      • Work with other stakeholders to identify risks to submissions, overcome hurdles and determine effective solutions to minimise these risks and any potential delays.
      • Triage and collate responses to questions from regulatory authorities and dictate response timelines to multiple stakeholders. Advise on strategy for complex questions, and communicate effectively and professionally with regulatory authorities where required.
  • Provide expert subject matter advice on all applicable regulations and on regulatory requirements to obtain the fastest possible approval of clinical trials in specified countries.
  • Support the Associate Director with planning and tracking of regulatory activities and agency interactions.
  • Collaborate cross-functionally to identify and assess the impact of Clinical Trial-related regulations; drive the implementation of changes to company processes, procedures, and training material to support these regulations as necessary.
  • Liaise with Global, Area, and Affiliate Regulatory Affairs, Quality Assurance, Regulatory Operations, Clinical Product Development and Supply Chain to identify, resolve, and elevate potential issues arising from regulatory submissions and maintenance of CTAs and/or compliance with company and industry standards.
  • Closely collaborate with management to ensure resources are appropriately allocated to provide adequate support for regulatory submissions and for cross department and/or organizational initiatives.
  • Apply expertise and sound judgement as related to CTAs and regulatory matters; candidate's decisions may:
    • Significantly impact the deliverables of clinical R&D programs on key geographic areas, possibly resulting in improving or deteriorating program timelines and quality, therefore registration files, marketing authorizations and ultimately market access, supply chain and sales.
    • Impact the management of patients exposed to experimental drugs.
    • Affect the company's image and credibility towards regulatory agencies.

Skills/Experience Required:

  • Bachelor's degree in any life sciences.

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@SRG.co.uk or +441753 589673

SRG
17/11/2019 10:47:36
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