Regulatory Specialist on a fixed-term contract
Candidates must have a university degree (in pharmacy, medicine, biology)
Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme. In Bulgaria Sanofi has been present since 1992, with a main office in Sofia. At Sanofi we are committed to the growth of our people, connected in purpose by career, life and health. Commitment is our Strength. Ready to grow together?
The local affiliate SANOFI BULGARIA EOOD is looking for Regulatory Specialist on a fixed-term contract, Bulgaria
• Within the framework of global business strategy support conduction of regulatory activities within the country and within the area/s of the responsibility. Liability for registration of the products from Sanofi group, process of obtaining MA, regular and systematic maintenance of registration in accordance to legislation requirements
• Take part into the preparation of registration plan, to follow the approval of new products, labeling update and new indications in coordination with a local business plan in terms of their timely industrial implementation.
• Organize, update and maintain all regulatory dossiers to the highest professional standards in line with Sanofi strategies and local legal requirements.
• Organize and update the regulatory databases of the registered and submitted product dossiers in the country.
• Review labeling and promotional material for compliance with local regulations and corporate procedures.
• Brings appropriate country regulatory expertise and support into the business strategies/projects in order to reduce as much as possible the time to market
• Propose regulatory solutions to business opportunities in a timely manner
• Create the appropriate level of communication with Health Authorities in order to facilitate registration process, discuss and challenge issues and negotiate solutions in the best interests of the company; participate in meetings with Health Authorities.
• Ensure product packaging and associated information are updated and maintained in accordance with the product license,
• Work with cross-functional teams to identify and implement improvements processes, Collaborate with the other departments
• Participation in the process for writing/updating local procedures (SOP or WI).
• Regularly send all updated product information to the concerned people within organization (medical, marketing, supply chain).
• Participate to the portfolio optimization by monitoring and providing information for regulatory fees and support budget preparation.
Experience & knowledge:
• University degree (in Pharmacy, Medicine, Biology)
• Good understanding of pharmaceutical market, professional experience at least 2 years (preferable) and knowledge of respective legislation in regulatory environment
• Strong personal capacity for learning new aspects of business.
• Professional attitude and well developed communication skills.
• Very good in organization and work with database. Having an eye for details.
• Self motivated and able to work alone and in team.
• Excellent English - verbal and written
• Computer skills- Excel, Word
If you are willing to learn; if you are creative and responsible; if you see yourself being a member of a dynamic team and want to gain insight into an international organization:
• PLEASE SUBMIT YOUR CV AND MOTIVATION LETTER BY 1st of August 2017.
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