Regulatory Affairs Manager - Senior

Highly Competitive
  1. Contract
  2. Senior/Director & VP
  3. United Kingdom
High Wycombe, Buckinghamshire
Posting date: 23 Jan 2019
RA.PD.21065_1548264895

Here is a chance to join one of the most globally known pharmaceutical organisations, who is looking to hire a Regulatory Affairs Manager based in High Wycombe on a contract basis. This job will be working a top 10 pharmaceutical company that works across a range of industries from medical devices to pharmaceutical and consumer goods, operating in over 60 countries.

Job Responsibilities:

  • Cross portfolio technical and administrative activities as required
  • Key therapy area regulatory support, including CVT attendance as appropriate Not Expected to: Routinely carry out cross-portfolio technical and administrative activities Be responsible for external strategic regulatory relationships. Develop budgets.
  • 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 patients.
  • 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. Compliance
  • Complete above activities to ensure compliance with all regulatory requirements
  • Develops and maintain in depth knowledge of regulations/legislation.
  • Supports EMEA with collection of RA competitive intelligence as required. Internal contacts
  • Support other departments based on their needs (e.g. Supply Chain, Quality, Medical, and Commercial) by providing documentation and information in response to requests. External contacts
  • Contact local Health Authorities to resolve general queries (some product specific) when these cannot be addressed internally ensuring a positive interaction in any communication. Miscellaneous
  • Support and contribute to GRA-EMEA initiatives as requested by Head of RA.
  • Contribute to initiatives around lessons learnt and change management to ensure efficiency gains.
  • Actively contribute to increasing the regulatory expertise of the team by mentoring of junior regulatory colleagues

Skills and Requirements:

  • Essential Technical Knowledge, skills and experience 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 Other special requirements Occasionally flexible work hours SOPs relevant to this role (including any regulations etc)

To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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