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REGULATORY AFFAIRS MANAGER (M/F) Leiden Netherlands,
Posted on : 22 March 2017
REGULATORY AFFAIRS MANAGER (M/F)
- The successful candidate will ensure the registration submissions, renewals and variations of the Marketing Authorizations of company s products, in accordance with the current regulations, in the different markets/countries where company operates, contributing for the Department and the Company s goals.
- Guarantee the preparation of documentation and the submission of applications to the Agencies, including new markets outside EU;
- Insure the preparation of responses and, in some cases, directly liaise activities with regulatory agencies; prepare and submit regulatory documents, as well as manage the regulatory archive;
- Communicate relevant regulatory information to multiple departments, making sure that the information is correctly interpreted and guidance is provided;
- Work with senior management to support the development and implementation of regulatory strategies, including global strategies, that ensure that procedures and policies meet the applicable regulations - taking also into consideration the regulatory environment;
- Keep up-to-date knowledge of relevant regulations, including being timely aware of emerging legislation and guidelines and contribute to ensuring company-level
- awareness and compliance.
For this role we are looking for a skilled professional in regulatory affairs with 5 years of experience in pharmaceutical industry, CRO s or authorities, that can demonstrate:
- Degree in Life Sciences;
- Previous and established experience in regulatory support;
- Well established contacts with relevant authorities, namely EMA and FDA;
- Experience working globally with several markets, outside EU is an advantage.
- Analytical and methodical profile with a solution seeker approach;
- Results and business oriented;
- Strong planning skills (project management mindset is an advantage); understanding projects or tasks in a holistic perspective;
- Strong communication; ability to negotiate and concisely express clear positions to stakeholders;
- Ability to build interpersonal relationships and work in teams;
- Fluency in written and spoken English essential. French skills will be highly valued;
- Availability to travel.
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