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Regulatory Affairs Manager

THE OPPORTUNITY

 

We are hiring a Regulatory Affairs Manager responsible for the management and execution of regulatory activities for Türkiye.  The job holder performs regulatory activities in compliance with internal and external requirements to support business continuity.

 

The job holder will be based in Istanbul, Türkiye and will report to the Head of Regulatory Affairs.

 

Responsibilities

  • Manage & execute the local RA activities according to Regional Operating Unit (ROPU) RA strategies and local business priorities within the defined timelines.
  • Maintain product registrations and RA databases; ensuring business continuity in compliance with internal and external regulations and requirements.
  • Provide regular regulatory intelligence on changes in the regulatory environment and opportunities to enable the business to realize risks or opportunities arising in the RA environment.
  • Collaborate cross-functionally and make sure that all relevant stakeholders are timely and pro-actively updated on relevant RA topics.
  • Have a strong interaction and partnership with the assigned authorities across in the country.
  • Maintain efficient relationships with related regulatory service providers (local agents and vendors).
  • Carry out agreed actions for the assigned global and local projects.
  • Can deputize the Operating Unit (OPU) RA Head in external & internal stakeholders’ engagement as required.
  • Support the OPU RA Head in the continuous development of the team.

 

Requirements

  • Bachelor Degree in Pharmacy, Chemistry, Chemical Engineering or in a relevant scientific education
  • At least 4-6 years pharma industry experience in regulatory affairs, preferably in a multi-national company in Türkiye
  • Excellent knowledge of local regulatory procedures and practices
  • Experience of direct interactions with Regulatory Authorities
  • Good knowledge of written and spoken English

 

What’s Next?

We are looking forward to receiving your application! We will then have a look at your profile. If we see a match, we will invite you for a screening interview.

 

Screening:

In order to comply with applicable export control laws, Boehringer Ingelheim periodically screens business relations (including job applicants) against sanctioned party lists (“SPL”). These checks may be performed by Boehringer Ingelheim or by any of its Affiliates. You acknowledge that Boehringer Ingelheim and/or its Affiliates will screen you against SPL and that for this purpose your personal data may be processed in relevant databases, including databases of third-party vendors that perform SPL screening for or on behalf of Boehringer Ingelheim or its Affiliates which may be located or accessible outside the EU. Boehringer Ingelheim is committed to ensuring an adequate level of protection of your personal data.

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