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Regulatory Affairs (CMC) Consultant a.i.
Pharmaceuticals: Regulatory Affairs
CMC, filing and submissions, European Marketing Authorization Application
About Our Client
Our client is a world leader in the distribution of chemistry and related products and services. They have large international distribution facilities and thereby serve a broad range of end markets. Due to expansion of their product portfolio, Univar is currently looking for a CMC Associate for the European pharmaceutical market.
You will have to liaise with consultants for developing and maintaining the Market Authorisation (MA) project plan. Another responsibility is to assure that the content of the electronic Common Technical Document (eCTD) meets the requirements of the local Regulatory bodies. In addition you have to ensure that the eCTD documents for modules 2.3 and 3 relating to regulatory submission, are collated and provided for review by Regulatory Affairs (RA). It is important that you can work closely with consultants, quality, marketing, legal, and other professionals across the company, to make sure the information for the modules 2.3 and 3 is complete compliant and well maintained. Furthermore, you also have to cooperate with suppliers and global regulatory agencies across the world, to secure the product license per country post European MA.
You will report directly to the Business Manager and work in an informal and motivated team. For this dynamic and all-round position we are looking for strong communicators who can liaise with suppliers, CMO's and other departments in the organisation.
Other responsibilities include but are not limited to:
- Assure follow up on post marketing commitments (e.g. stability studies);
- Work closely with suppliers and test houses to develop test methods required for Drug Substance and Drug Product to comply with current regulations and guidelines;
- Closely interact with Contract Manufacturing Organisations (CMOs) on the production technology and processes in detail;
- Designing process development studies that confirm critical quality attributes (CQAs) and critical process parameters (CPPs) for validation;
- Providing support with investigation of process deviations and resulting CAPA plans;
- Cooperate with other disciplines regarding risk assessments on supply of product;
- Review and authorise Master Documents.
The Successful Applicant
- Relevant Bachelor or Master's Degree;
- 3 years of experience with manufacturing activities in a pharmaceutical environment and CMC;
- Knowledge and interpretation skills of FDA, ICH or cGMP regulations and guidelines;
- Strong problem solving, trouble shooting and project management skills;
- Experience with process development, validation of processes and analytical methods, stability studies and analytical methods is a plus;
- Excellent communication skills in English (verbal and written).
What's on Offer
Excellent hourly tariff.