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Posted on : 22 March 2017

Project Description

Work Opportunities REGULATORY AFFAIRS MANAGER (M/F), Porto, Portugal The successful candidate will ensure the registration submissions, renewals and variations of the Marketing Authorizations of BIAL’s products, in accordance with the current regulations, in the different markets/countries where BIAL operates, contributing for the Department and the Company’s goals. KEY ROLE:• 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-levelawareness and compliance. REQUIREMENTS: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.


Leiden Netherlands

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