Manpower Suadiye - Regulatory Affairs Specialist
Regulatory Affairs Specialist
City: İstanbul Anadolu
Date of Post: 10 September 2016
Number of Person: Unspecified
We are seeking for a 'Regulatory Affairs Specialist' to join the team of our leading pharmaceutical company.
- Provides regulatory expertise and executes the submission of the new products in the market (including product line extension, new indication), regulatory maintenance of marketed products (including product maintenance as manufacturing or labeling variations, renewals, etc.) aligning related written procedures,
- Work according to the company procedures and policies that assures consistent accurate and efficient processing of required submissions,
- Aligns global regulatory partners’ goals and objectives through appropriate database tools ensuring desired affiliate performance,
- Makes registration submission of GMP (good manufacturing practices).
Bachelor’s degree in health sciences (pharmacy, chemical and medical),
Minimum 2 years of related experience in pharma industry,
Ability to work in a regulatory environment both independently and within a team,
Ability to exercise judgement in accomplishing goals,
Good knowledge of regulations and guidelines,
Organizational skills and detail-orientation,
Ability to prioritize multiple tasks/projects,
Strong knowledge of MS Word, Excel and Outlook,
Proficiency in English language both oral and written,
Availability for travel.
Manpower Türkiye İş Kurumu Özel İstihdam Bürosu izin belgesi sahibidir. Belge No:06 Tarih:1.9.2013