Regulatory Affairs CMC Manager / Snr Manager – Small Molecules, Berkshire, UK

Reference: Oli10493BB

Expiry Date: 20-09-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

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Job Description

Regulatory Affairs CMC Manager / Snr Manager – Small Molecules, Berkshire, UK

About the company

Our client is growing, and to strengthen their Global Regulatory Affairs CMC team, they are looking to hire a Global Regulatory Affairs Manager / Snr Manager in Berkshire, UK.

This is an established Pharmaceutical company that has been transforming patients’ lives for decades, developing novel medicines and new generation therapies. This is an R&D driven business that has been successfully pushing the boundaries of what is possible, innovating and making a real difference to patients’ lives.

This is an opportunity to:

  • Lead assigned regional projects and take responsibility for the regulatory CMC support of chemical entities throughout the Life-Cycle (early to late development, CTA writing of IMPDs and INDs, authoring CMC sections of initial MAA/BLAs/NDAs and module 3 for post approval variations)
  • Contribute to the preparation of global regulatory CMC submission documentation to deliver timely approvals
  • Define, plan and implement regional regulatory CMC strategy and have input into the global regulatory CMC strategy
  • Lead and/or provide regulatory CMC input to Health Authority responses - authoring and managing the interactions with agencies on CMC matters in assigned regions. 

You will be responsible for:

  • Taking accountability by managing regulatory CMC projects yourself and authoring global CMC documentation (based on technical source reports) for submissions in line with agreed global regulatory strategy
  • Developing and implementing the regional CMC regulatory strategy and submission plans for assigned small molecule projects to deliver timely approvals
  • Ensuring effective communication of CMC regulatory strategy, risks, and overall plan for assigned projects to the Regulatory Affairs Teams and cross functional teams as delegated and agreed by the Global Regulatory CMC Lead.

 You should have:

  • At least 4-5 years of relevant pharmaceutical industry experience in a regulatory affairs CMC function. Previous experience in pharmaceutical manufacturing, analytical development and QA/QC technical field would be an advantage
  • Proven track record of successful writing / authoring and contribution to delivering regulatory CMC sections of CTAs, MAA/NDAs or Variations for chemical or biological entities
  • “Hands on”, “Can do” attitude and problem-solving abilities working within the regulatory affairs and enjoying a multicultural, international matrix environment where English is the business language.

Package, flexibility & Bens

  • My client is offering Manager or Senior Manager grading, for this position, including a bonus, and incentives plan. The role comes with great overall package and great career and promotion prospects
  • The company is willing to consider individuals that want to work from home for 2 days a week post-Covid
  • You will receive continual training and mentoring, from individuals with 15-20 years each in regulatory CMC
  • During the next few months, my client will hire and on board you virtually, so you will be interviewed, inducted and on-boarded from home. After Covid-19, this role will be based in Berkshire, UK.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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