Director Regulatory Affairs

Vor 3 Tagen

München, Deutschland Gilead Sciences Vollzeit

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

**Job Description**:
Director Regulatory Affairs (M/F/d)

In our German affiliate we have an opening for a leadership role within our local Regulatory Affairs team. The Director Regulatory Affairs (M/F/d) leads a team and reports to the Senior Director Regulatory Affairs, country head Regulatory Affairs. The position is office based on-site in Martinsried, Munich and requires fluent German language skills.

Detailed description:

- Ensures compliant labelling for Gilead medicinal products and manage timely updates for assigned product(s)
- Lead or support country/national scientific advice and / or pre-submission meeting preparation and follow-up
- Provides strategic regulatory advice as appropriate including input into clinical development programmes
- Support for communicating important changes to the local Regulatory and RSQ function/activities acting as a consultant to local Affiliate, regional, Intl or Global RA teams
- Manages interactions, negotiations and communication with local HAs and acts as the main point of contact for the local HAs for specific topics/products under their responsibility
- Provides or contributes to the Vision and Direction for the RA organization at the country level in line with global/Regional RA and local Affiliate Visions and sets clear goals and objectives in line with the global RSQ strategy
- Support or management of quality defects, falsified or counterfeit products, batch recalls and stock out as required
- Responsible for the review of promotional and non-promotional material and approval, certifies materials where appropriate for assigned product(s)
- Might act as a local Gilead representative as required by local law e.g. Qualified Person QA, QPPV, Responsible Person PV, RP QA, National qualified person for scientific service (Informationsbeauftragter)
- Serve as a core Regulatory member in updating and preparing the Company for major changes in regulatory legislation and competitor information in the country for assigned product(s) or projects and contributes to guideline and regulation development Represents Regulatory Function at internal and external meetings or working parties building recognition as a thought leader
- Lead or manage work in additional countries e.g. distributor markets as required
- Training or coaching of staff on key regulatory activities and updates.

General Responsibilities:

- Ensures that Gilead complies with country’s applicable legislations and regulations linked to the Marketing Authorization (MA) / local license as MA Holder or as local legal representative of the MA Holder
- Ensures that the medicinal products in her responsibility can be developed, authorized and maintained on the market
- Serves as a core member or may lead cross functional project teams locally and regionally. May also serve as a core member in global cross-functional teams.
- Senior represenstative of the Regulatory function and RSQ at internal and external meetings
- Manages a team of Regulatory professionals for assigned BU(s)/product(s)
- As the responsible person (RP) for scientific information acc to section 74a of the German Drug law (AMG) (“Informationsbeauftragte”) ensure compliance with all regulations applicable to this position, e.g. HWG, AMG, FSA Kodex.

Requested knowledge for this position:
Professional Training:
University degree preferably in Natural Sciences or Pharmacy

Experience:
Solid experience in RA or other relevant industry experience
- Special_ knowledge:_
- Excellent knowledge and proven experience in understanding and implementing regulatory requirements in Pharmaceutical / Biotech Industry including ICH requirements regional and local requirements and an understanding of current trends in the local

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