CMC Contractor- Regulatroy
A leading pharmaceutical client is searching for a Regulatory CMC Contractor to join their team in Hertfordshire, UK. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.
Based on MDC policy, accomplish product creation tasks for the fulfillment of patient reality. Assess current status of CMC-regulatory information and propose enhancements that bring a reduction in timelines for product registrations or post-approval variations. The Contractor will cooperate with stakeholders for the advancement of assigned projects and for the maintenance in quality of the company's products. This CMC Contractor will lead the preparation of submission documents (IMPD-Q, Module 3 for MAA or license variations and provide response to questions from health authorities in a timely manner) within the EMEA region.
- Have accountability for the quality of submissions as assessed by health agencies.
- Provide support to CMC-regulatory group function as required.
- Understand the current pharmaceutical industry environment and mitigate future risks from a CMC-regulatory perspective.
- Assumes regulatory accountability for the CMC aspects of the projects/products goals and objectives
- Provides oversight for the CMC components of all regulatory submissions (IND or CTA, NDA or MAA, amendments, variations, scientific advice briefing documents, CMC agency communications etc.) to ensure that quality documents are prepared in compliance with the applicable regulatory requirements
- Engages in or leads CMC sub-teams to plan, prepare and complete the CMC sections of major submissions
- Leads effective responses to Health Agency CMC questions
- Interacts with and influences external stakeholders
- To be a main contact point within the company group, for communications relating to Quality/CMC issues
- Supports regulatory strategy and manages timelines to meet project needs
Skills and Requirements:
- College or University degree in an associated functional discipline (Chemistry or Pharmacy)
- Doctorate or higher degree desired (e.g. MSc, JD, Pharm D, or PhD in life sciences)
- Extensive regulatory experience plus additional related experience (i.e., in Research and Development or Manufacturing, clinical marketed products, etc.), preferably including some broader industry experience.
- An accomplished working knowledge of both the formulation and analytical aspects of R&D in addition to the above regulatory experience.
- A strong working knowledge of the application of the principles of chemistry to drug synthesis.
- Experience of the development of solid, liquid and parenteral dosage forms, including process validation and/or analytical testing.
- Experience dealing with agencies and preparation of briefing documents relating to Quality issues.
- Ability to express a scientific opinion clearly and concisely and to defend regulatory decisions under pressure.
- High organisational skills and time management.
- Confidence in dealing with Regulatory Authorities.
- Ability to manage multiple projects and multiple tasks.
- Ability to work in a matrix environment.
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 Numhom Sudsok on +44 203 8718 093 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.
Highly Competitive Salary
At ProClinical, we are seeking an individual to fill the role of Senior RA, CMC Manager, based in Boston, MA.