Job objective:

• Preparation and supervision of the submission of registration documents to local BBraun subsidiaries and competent authorities, in accordance with local guidelines and the Global Regulatory Affairs and Lifecycle Management strategy of the headquarters.

Tasks and Responsibilities:

• Checking and submission of documents for registration and maintenance on the market (variations, renewals, new registrations).
• Preparation of specific GRA documents in collaboration with other product responsible persons and relevant departments, in the context of regulatory or department issues.
• Obtaining certificates or legalizations internally/externally, if necessary, and ordering required translations.
• Monitoring and preparing procedures in collaboration with LRA, storing relevant documentation and correspondence in the defined manner on our drives.
• Tracking the completion of RA procedures, transmitting information (approval/rejection) and resulting documents to all involved departments according to internal guidelines and procedures.
• Sending dossiers to LRA, communicating with LRA.
• Dispatching registration documents within the scope of regulatory submissions.
• Ordering and tracking the dispatch of samples and standards required by authorities.
• Ensuring deadlines are met and due dates are maintained.
• Communicating with other functional groups within GRA, other departments, or local representatives worldwide.
• Regular travel to B. Braun in Sempach, Switzerland (1- 2 / year) 

Professional competencies / Ideal candidate:

• University degree in Pharmacy, Medicine, Chemistry, Biology or a related field
• Postgraduate studies will be an advantage
• 1-2 years professional experience in regulatory affairs
• Fluency in English (written and verbal)
• Proficient in MS Office
• Good organisational skills, attention to detail, high level of personal responsibility and commitment
• Acts analytically and systematically
• Actively works on personal development
• Proactively adapts to change
• Excellent communication and teamwork skills, flexibility and resilience

Benefits:

• Unlimited period contract;
• Annual performance bonus;
• Hybrid working mode (working from home in a proportion of 50-60%) – Office work takes place in Sânandrei, Timis County;
• Meal tickets;
• Health subscription (free or discounted medical services);
• Wellhub subscription (previously 7 Card);
• A premium for family events, according to the Collective Labor Agreement;
• Partial settlement costs for the purchase of eyeglasses;
• Free coffee and dynamic work atmosphere.

B. Braun Shared Services Romania | Adriana Nai |