Senior Regulatory Affairs Associate CMC

Employer
Michael Page
Location
Cambridgeshire, Cambridge, England / Cambridgeshire, England / Peterborough, England, Cambridgeshire
Salary
Negotiable
Start date
13 Jan 2023
Closing date
12 Feb 2023

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Exciting opportunity to join a growing pharmacetuical business, joining a high performing Regulatory CMC team.

Client Details

A pharmaceutical company delivering drug treatments and services for patients, focusing on rare metabolic and neurological genetic conditions.

Description

Senior Regulatory Affairs Associate CMC

  • Primary point of contact for chemistry, manufacturing and control (CMC) regulatory documents.
  • Liaise with internal stakeholders as well as Contract Manufacturing Organisations to assemble and review key quality documents to ensure regulatory compliance.
  • Preparation of high-quality CMC regulatory documents for small molecule products to support global regulatory submissions.
  • Collaborate with Product Leads to develop Target Product Profile and Regulatory Strategy.
  • Act as the Information and Regulatory Change Control Owner for CMC activities and oversee delivery for the team.
  • Work to agreed deadlines, with ability to respond readily to changing events and priorities.
  • Opportunity to grow within the role and take leadership in CMC strategy with a future potential of line management.
  • Create and/maintain regulatory systems as required (submission tracking, gap analysis etc.)

Profile

Senior Regulatory Affairs Associate CMC

  • Degree in Pharmacy, Chemistry or related discipline, or with extensive experience of working within CMC in Regulatory Affairs (3 years min).
  • An accomplished working knowledge of the formulation and / or analytical aspects of pharmaceutical R&D (minimum 2 years).
  • Excellent written and oral communication.
  • Ability to work in a proactive and autonomous manner, as well as being part of a team with the ability to establish strong relationships and liaise effectively with Contract Manufacturing Organisations worldwide
  • Good problem solving and critical thinking in complex, multidisciplinary situations (ideally this would include some programming experience (VBA etc).
  • Demonstrate a 'can do' attitude to assume responsibilities beyond own space when the circumstances demand.
  • Ability to focus, work with attention to detail and retain critical information.
  • Effective organizational / project management skills.
  • Ability to express a scientific opinion clearly and concisely and to support the defense of regulatory decisions.
  • Be proficient in the use of IT packages such as Word, Excel and Document Management systems (specifically Veeva).

Preferred experience:

  • CMC Regulatory Affairs experience; planning, authoring, reviewing and project management of regulatory submissions.
  • Global experience (including EU, US, CA & UK), in the following types of CMC submissions:
  • MAAs/NDAs and/or Lifecycle Management for medicines and managing the related responses to questions
  • Briefing documents for Scientific Advice Meetings (Pre-IND, Type C Meetings)

Job Offer

Senior Regulatory Affairs Associate CMC

  • Seek to have a profound impact on patients and their families;
  • Work across a range of different disease states;
  • Opportunity for professional development and training;
  • Help shape the culture and future of an emerging pharmaceutical company with a grand vision;
  • Collaborate with a growing team of experienced professionals;
  • Learn from a strong leadership team a with a proven history of success.
  • Competitive salary based on experience
  • Performance based bonus
  • Opportunity to join a fast growing and ambitious business
  • Company pension scheme
  • 100% employer paid membership for Private Health Insurance
  • Life and Critical Illness Insurance
  • Corporate Gym membership
  • Regular team building events and an agile working environment

Company

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.

Find Us
Website
Telephone
0845 6060 610
Location
Michael Page International Ltd,3rd Floor
The Switch Building
1‑7 The Grove
Slough
SL1 1QP
GB
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