Director - Regulatory Affairs CMC - MSD - Schwabenheim
Job description
Director Regulatory Affairs CMC
MSD is one of the largest providers of innovative medicines, vaccines, biologic therapies for human and animal health products. Through extensive initiatives, programs and partnerships specifically we show our commitment to improving access to health care, so people can live healthier all over the world. MSD Germany employs approximately 2,400 employees of which 600 are working for MSD Animal Health (formerly known as Intervet). In Schwabenheim our MSD Animal Health Innovation center performs global research and development for veterinary medicinal products
In order to strengthen our EU Pharma Regulatory CMC we are currently looking for a Director Regulatory Affairs CMC. Europe Pharma Regulatory CMC is a truly global department. Together with an US based team it is responsible for global CMC RA for MSD Animal Health. The team in Europe consists of approximately 10 people, most of them at PhD level.
Purpose of the job
The purpose of the team is to ensure CMC (chemical/pharmaceutical and manufacturing) regulatory affairs expertise for the global pharma product portfolio for the development, licensing and maintenance (compliance) of all pharmaceutical products. You will support new global product development initiative to meet global regulatory CMC requirements thus ensuring regulatory CMC compliance. For this you’ll manage multi-national organization by developing and training direct reports.
Key tasks and responsibilities
* Ensure that the pharma product licenses are maintained and defended globally by providing regulatory and technical CMC expertise (data, information, advice) to the global markets.
* Identify, assess, initiate and coordinate all required CMC maintenance activities in coordination with MMD (Merck Manufacturing Division).
* Ensure the provision of regulatory CMC expertise and regulatory strategy for global product developments. RA CMC actively participates in project development teams and provides regulatory CMC know how and expertise with regard to the global quality requirements.
* Ensure regulatory compliance for the CMC documentation.
* Develop regulatory CMC strategies to improve and optimize the entire product licensing process.
* Follow the emergence of new regulatory CMC requirements on a global scale. Analyze new and emerging requirements and assess their impact on the development pipeline and the existing pharmaceutical product range.
* Develop and maintain contacts to regulatory authorities (EU and US) to represent and defend the company interests; building a regulatory network of competent partners.
* Participate in industry association committees and initiatives as scientific expert, as appropriate, to represent and defend the companies interests. Continue as company member in the Quality ad hoc Group of IFAH-Europe.
* Ensure that the global regulatory affairs CMC personnel are well managed, resources optimally allocated and utilized and that high quality working standards are maintained. Guide, motivate and develop CMC staff according to corporate management principles. Make personnel decisions by agreement with the superior and HR department.
Qualifications
* A university degree in pharmacy or an equivalent Life Science degree
* Minimum of 5 years’ experience from a CMC regulatory position within the animal health business (preferred)
* Minimum of 2 years` experience leading an international team
* Solid understanding of animal health product research and development processes and project management expertise
* Knowledge of EU, US and non EU regulatory guidelines.
* Strategic thinking and ability to work in a global matrix environment
* Strong people manager able to empower and motivate highly skilled professionals
* Strong communication and negotiation skills
* Fluent business English language (German is an advantage)
* Office & work location are based in Schwabenheim
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