For our client, an international pharmaceutical company, we are looking for a Regulatory Manager in Porto, Portugal. The company's mission is to discover, develop and provide therapeutic solutions within the area of health.
For our client, an international pharmaceutical company, we are looking for a Regulatory Manager in Porto, Portugal. The company's mission is to discover, develop and provide therapeutic solutions within the area of health. With products available in more than 50 countries throughout four continents, the company's commitment is to contribute for the improvement of Human Health and the quality of life of people from all over the world.
- 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.
Commensurate to skills and experience, competitive package.