Director Regulatory Affairs

at  Gilead Sciences

For Current Gilead Employees and Contractors:
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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:

• Manages or prepares technically complex regulatory submissions to local Health Authority (HA), including initial MA application, variations, safety reports, risk minimization measures, Dear Healthcare Provider Communications, compassionate use, early access, license renewals as well as clinical trial applications and amendments, which may require extensive interaction with departments outside of Regulatory Affairs (RA)
• 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
• Helps ensure compliance with local law and regulation and consistency with global procedural documents including acting as a subject matter expert or the management of audits and inspections within the affiliate
• 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 affiliate
• Must be capable of developing and implementing regulatory strategy and managing complex negotiations with a HA
• Knowledge in quality assurance, promotional and non-promotional review as well as pharmacovigilance and market access
• People management experience
• Experienced leader of projects and teams
• Excellent working knowledge regarding country/national and regional HAs (people, system, processes and requirements) Vision and direction setting
• Leadership skills showing the ability to influence externally, cross- functionally and within RA
• Extensive experience working with local HA at a senior level
• Must be capable of leading project teams and working cross functional
• Good decision making and prioritization skills are important
• Excellent verbal and written English language skills, organization skills and interpersonal communication skills required

Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively “Gilead” or the “Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your
Internal Career Site
to apply for this job

• 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