Regulatory Affairs Manager/Specialist (Contractor)

TAKEDA İLAÇ SAĞLIK SAN.TİC.LTD.ŞTİ.

With around 30,000 people working in approximately 70 countries we are a truly global partner for better health. By always putting people first, we empower employee so everyone can develop to his or her full potential. 

Takeda Turkey operates since 2009 in Turkey; we are providing better health to patients in different therapeutic areas which are Oncology, Hematology, Genetic Diseases, Immunology, Gastroenterology, and Primary Care

Principle Accountabilities:

•             Prepares, submits and follow-up GMP submissions and Registration processes (NDAs, new indications, renewals, variations, safety related applications, packaging material and SPC updates etc.) in compliance with the local law/regulations and according to the planned submission timeliness

•             Ensures cross functional cooperation with market access, medical and sales/marketing functions on all questions linked with regulatory affairs

•             Collaboration with medical & pharmacovigilance units for safety and labelling issues

•             Collaboration with commercial unit for supply continuity of the products

•             Support to update corporate regulatory databases appropriately and to keep documents/files related to Regulatory Affairs in trustworthy way

•             Contributes to preparation of launch plans by providing estimation for the submission and approval dates and participate in the related meetings, informs relevant people (local or regional) immediately in case any update is required in registration/launch plans

•             Contributes to regulatory affairs strategy and business plan development

•             Participates in negotiations with relevant Authorities and registration committee members when necessary and maintains strong relationship

•             Follows up any updates on the latest regulations. Predicts potential risks to find solutions and ensures revision of registration plans when required, and provides intelligence to the relevant people (management team, regional contacts etc.)

•             Keeps track of the key issues impacting the pharma industry with respect to regulatory processes, GMP inspections, intellectual property, competitor intelligence etc.

General Qualifications:

•             BSc Degree in Pharmacy, Chemistry or Chemical Engineering, MSc degree in life sciences is preferred

•             Minimum 5 years of experience in Regulatory Affairs and GMP procedures

•             Excellent command of written and spoken English

•             Good command of MS Office Applications

•             Ability to work within a team efficiently and independently when needed

•             Good problem solving and analytical skills

•             Efficient planning and execution

•             Delivering high quality results

•             Strategic and flexible thinking, proactively seeks to understand views of others

•             Proactive person who is able to remain calm under pressure and prioritize the work without supervision

•             Positive outlook and effective, flexible approach to team working

•             Manages diverse relationships

•             Understands market and business needs