Regulatory Affairs Associate
Rapidly Expanding Pharmecutical Company
Times Tech Track 100 Company
About Our Client
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.
- 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.
The Successful Applicant
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
What's on 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.