Regulatory Affairs Associate

Employer
Michael Page
Location
Cambridge, England, Cambridgeshire
Salary
Negotiable
Closing date
22 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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Very exciting opportunity for a Regulatory Affairs Associate to join a high growth and ambitious pharmaceutical business.

Client Details

My client is a pioneering UK pharmaceutical company who are growing rapidly and have some very exciting and ambitious plans over the next 5 years . My client works closely with patient groups and health care professionals to understand unmet needs. By collaborating with academic communities , they intend to translate innovations into medicinal products that patients and caregivers wants.

They were recently awarded with a spot in the times tech track 100.

Based in Cambridge - there is the opportunity to work part of the week from home.

Description

  • Compile CMC documentation (M3 and M2 summary documents) for eCTD post-approval submission for main markets such as US, Canada, EU, UK and International markets (MENA, LATAM, APAC)
  • Assist in reviewing change control documents, batch records, and other technical documents.
  • Provide support to the Regulatory department by co-ordinating requests for original and legalised documentation to support applications for international product licences.
  • Monitor the current regulatory environment for changes (and opportunities) that may impact future regulations, guidance, policy, and legislation.
  • Create and maintain a log of Market Specific (submissions) Intelligence:
  • Requirement for CPPs.
  • Lessons learnt and experiences with different Health Authorities etc.
  • Gather and analyse available regulatory information from key regulatory websites (e.g.FDA, EMA, ICH etc.);
  • Communicate the implications of the regulatory intelligence finding to senior members of the team and other functions.
  • Provide and maintain MA documentation support by managing submission tracking spreadsheets and databases, and monitoring compliance file generation.
  • Work with Cloud based document management system for key registered details
  • Work to agreed deadlines, with ability to respond readily to changing events and priorities.

Profile

Successful Regulatory Affairs Associate

  • A minimum of a B.Sc. in a Life sciences subject (Pharmacy, Chemistry, Biology or related discipline).
  • Post-approval experience with at least one of the main Regulatory authorities is required (FDA, Health Canada, EU). Minimum experience required 2 years.
  • Experience in ROW markets post-approval maintenance would be a plus
  • An understanding of manufacturing process, in process control, analytical process, stability studies would be beneficial
  • Effective organisational/project management skills.
  • Demonstrable aptitude for IT packages such as Word, Excel, Access & PowerPoint.
  • Experience of database design/programming languages would be desirable

Job Offer

  • Competitive salary based on experience
  • Performance based bonus scheme
  • Opportunity to join a fast growing and ambitious business
  • Development and growth opportunities
  • Smart environment and vibrant working conditions
  • Great holiday entitlement, plus bank holidays
  • Gym Membership
  • Childcare voucher scheme
  • Income Protection
  • Life Insurance
  • Health insurance (BUPA)
  • Contributory Pension Plan.

About us The original PageGroup brand, Michael Page is comprised of 25 disciplines – each providing a service to a specialist area of the market. We recruit permanent, temporary, contract and interim opportunities, typically from second/third job levels upward. Businesses we work with range from SMEs to global blue-chip organisations.

LinkedIn award

 

The UK

Our business started life in the UK in 1976, as a two-man operation above a laundrette. Nearly four decades later we have more than 7000 employees and a global office network, while growing our UK market coverage too.

With offices from Aberdeen to Bristol and Cardiff to Cambridge, and more than 25 specialist businesses we have the track record to handle your recruitment requirements or job search. We combine our local knowledge and global expertise to provide a specialised service to both employers and candidates.

Contact Us
  • Michael Page International Ltd,3rd Floor
  • The Switch Building
  • Slough
  • SL1 1QP
  • United Kingdom
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