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Senior Regulatory Affairs Project Manager

  • Job reference: 923255
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 08/01/2019

Orion Group are recruiting for a Senior Regulatory Affairs Project Manager on behalf of our Multinational Pharmaceutical Client on an initial 6 month contract based in the Buckinghamshire Area

Role Purpose
Management of processes to ensure compliance with regulatory requirements and an
inspection ready culture which includes:

  • Cross portfolio technical and administrative activities as required
  • Key therapy area regulatory support, including CVT attendance as appropriate.

Key Role Activities

  • Provide Regulatory support for a portfolio of promoted and non-promoted products.
  • Prepares and submits regulatory documentation with support from RSMO as required.
  • Monitors deadlines for different projects to ensure they are met or escalated to a Senior
    Regulatory manager and/or Head of RA.
  • Responsible for the content of the local labelling documents released to prescribers and
  • Prepares and distributes local labelling documents within stipulated timelines following
    receipt of relevant approvals from RRR.
  • Prepares for and manages local procedures following the EMEA Regulatory Affairs
    strategic plan, assuring timely execution and compliance.
  • Partner with allocated CVT to provide RA expertise and support Implements of Risk
  • Management Plans and when required co-ordinates cross functional team to
    implement/update Risk Management Educational Material.

Desired Experience of the successful candidate:

  • Regulatory Affairs experience at operational level.
  • Direct experience and strong knowledge of general regulatory requirements and guidelines.
  • Strong data gathering and analytical skills are essential.
  • Strong persuading/ influencing, negotiating skills are required.
  • University Degree in Pharmacy, Biology, Chemistry or related Life Science.
  • Registration with official governing bodies e.g. General Medical Council, Royal Society of Pharmacists.
  • Member of the Organisation for Professionals in Regulatory Affairs.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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