Regulatory Affairs Manager

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 Buckinghamshire 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.

Role Overview:

• Management of processes to ensure compliance with regulatory requirements and an
  inspection ready culture This includes:
• Cross portfolio technical and administrative activities as required
• Key therapy area regulatory support, including CVT attendance as appropriate
• 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.
• 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.
• Support other departments based on their needs (e.g. Supply Chain, Quality, Medical,
  and Commercial) by providing documentation and information in response to requests.
• Contact local Health Authorities to resolve general queries (some product specific)
  when these cannot be addressed internally ensuring a positive interaction in any
  communication.
• 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
• Conduct formal performance and career conversations with all direct reports according
  to the framework set
• Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company
  policies and SOPs (Standard Operating Procedures) are met and appropriately managed
  when planning projects, developing materials, executing projects and contracting vendors
• Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules,
  Promotional Materials rules) are fully understood, appropriately managed and complied with
  when planning projects, developing materials, executing projects and contracting vendors
• Ensure inspection readiness with respect to personal training compliance, and availability of
  recent CV and individualized Job Description
• If commissioning contractors or third-party organisations, put contracts in place and provide
  training so that these individuals also act in accordance with Johnson & Johnson HCC
  requirements when interacting with Healthcare Professionals and report adverse events
  and complaints (as above).

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 0789 542 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.