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Regulatory Affairs Specialist

Job ID 1603158 Date posted02/21/2017 Location Istanbul, Turkey;

     QUALIFICATIONS

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 employees 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 Gastroenterology, Diabetes, Respiratory and Pain.

We are currently looking for a strong healthcare profile with the right attitude to join our Market Access, Regulatory and Public Affairs Department as "Regulatory Affairs Specialist".

Job Purpose:

The role has responsibility for all of Takeda activities in Regulatory Affairs including interactions with regulatory authorities, government bodies and lobbying interactions with the Regulatory Affairs area.,

Principle Accountabilities:

  • Keeps track of the key issues impacting the pharma industry with respect to regulatory processes, GMP inspections,  intellectual property, etc
  • Follows up any updates on the latest regulations. Predicts potential risks to find solutions and ensures revision of the Takeda Turkey’s registration plans when required, and provides intelligence to the relevant people (management team, regional contacts, etc.)
  • Contributes to the regulatory affairs, market access and government affairs department strategy and business plan development 
  • Ensures the cross functional cooperation with medical and sales/marketing functions on all questions linked with regulatory affairs
  • Contributes to the preparation of Launch Plans by providing estimation for the submission and approval dates and participates in the related meetings
  • Informs relevant people (local or regional) immediately in case any update is required in Takeda Turkey registration/launch plans.
  • In the scope of achieving new license approvals and continuity of existing licenses;
  • Prepares, submits and follows-up of Takeda Turkey’s GMP Inspection submissions and Registration processes (NDAs, line extensions, new indications, renewals, variations, license in / out applications, safety related applications, packaging material and SPC updates etc)  in compliance with the local laws/regulations and according to planned submission dates
  • Collaborates with Medical & Pharmacovigilance Unit for safety & labeling issues.
  • Participates in the negotiations with relevant Authorities and registration committee members when necessary and maintains strong relationship 
  • Ensures competitor intelligence is provided to relevant people
  • Participates in regulatory, pricing and reimbursement group meetings of industry associations (e.g. AİFD, İEİS).
  • Supports to update corporate regulatory databases appropriately and to keep documents and files related to Regulatory Affairs in trustworthy way.
  • Supports preparation and updating of regulatory budget.

Qualifications

General Qualifications:

  • MSc and BSc Degree in Chemistry or Pharmacy
  • Excellent command of written and spoken English
  • Experience: Min.2 years of working experience.
  • Experienced in Regulatory Affairs and GMP procedures
  • Good command of MS Office Applications
  • Ability to work within a team or independently as needed
  • Good problem solving and analytical skills
  • Understands market and business
  • Productive and efficient in planning and executing work
  • Delivering results
  • Strategic and flexible thinking - proactively seeks to understand views of others
  • Proactive person who is able to remain calm under pressure and prioritise work without supervision
  • Positive outlook and effective, flexible approach to team working
  • Manages diverse relationships
  • Delivers high quality results


Schedule
Full-time