Sr. Director (m/f/d) Head of Regulatory Affairs Germany

Job Description

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

Sr. Director (m/f/d) Head of Regulatory Affairs Germany

Job Responsibilities

· Provides the Vision and Direction for the RA organization in Germany, in line with global/regional RA Development Organization and Commercial Visions and sets clear goals and objectives in line with the Development Organization strategy

· Regulatory lead on the German leadership team and ACE affiliate Regulatory core leadership team, providing cross functional support and strategic advice

· Ensure that Gilead fulfills all relevant requirements linked to the MA/local license as MA Holder or as local legal representative of the MA Holder for the region

· Crisis management functional lead in the region

· Ultimately responsible for German resource and budget planning and utilization

· Lead communicator to the German Regulatory team for important changes to the local, regional, international and global Regulatory and Development Organization function/activities

· Manages German Reg Affiliate team and leads German Regulatory activities, is responsible for the German regulatory teams deliverables, professional development and putting in place succession plans for critical roles

· Oversees all regulatory activities in Germany, acts as strategic advisor or lead on very complex or challenging issues

· Advises Reg Heads on country/national scientific advice and / or pre-submission meeting preparation and follow-up challenges

· Input to the International and global regulatory strategy, upon request, including input into clinical development programmes

· Ensures compliance with local law and regulation and consistency with global procedural documents for all aspects of the German Affiliate Regulatory work

· Leads or serves as a core member on local, regional, international and global improvements, initiatives and taskforces

· Expert advisor to international and local promotional material review teams

· Expert advisor to local Gilead representative as required by local law e.g. Qualified Person QA, QPPV, Responsible Person PV, RP QA, etc and the respective regional functional teams

· Acts as an expert to local Affiliate, regional, Intl or Global RA teams on German Affiliate matters

· Leads risk assessments on critical or major regulatory issues and changes in Germany, and develops mitigation strategies as required

· A regulatory expert in updating and preparing the Company for major changes in German regulatory legislation and competitor information, contributes to guideline and regulation development and develops strategies to optimize the outcome

· Leads and is an ambassador for RA and the Development Organization at internal and external meetings or working parties building recognition as a thought leader

· Mentoring, training and coaching regulatory and non-regulatory staff

Knowledge & Skills

· Expert leadership skills showing the ability to influence externally, cross-functionally and within global Development Organization and RA

· Excellent compelling vision and direction setting

· Extensive experience working with local HA and Trade Association at a senior level

· Expert in developing and implementing regulatory strategies and managing challenging discussions with the local HA

· Excellent leader of complex cross functional projects and teams

· Expert people management and development experience

· Extensive productive cross functional internal and external networks

· Expert influencer, negotiator and decision maker

· Excellent decision making and prioritization skills

· Excellent verbal and written English language, organization skills and interpersonal communication

Education & Experience

· 16+ years of experience in RA or other relevant industry experience with BS/BA or 14+ years of experience in RA or other relevant industry experience with advanced degree. Degree in a scientific field is preferred

· Expert diverse knowledge and proven experience in understanding and implementing regulatory requirements in Pharmaceutical / Biotech Industry, including ICH requirements and international requirements and have an understanding of current trends in the local affiliate

· Expert in developing and implementing very complex regulatory strategy and managing challenging negotiations with a HA

· Excellent knowledge of quality assurance, promotional and non-promotional review as well as pharmacovigilance and market access

· Expert in working and leading cross-functional project teams

· Excellent people management experience

· Expert working knowledge of country/national and regional HAs and the local Trade Associations, recognized as a thought leader. Excellent knowledge of developing trends in the local rules and regulations and the potential impact to the organization

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 apply via the Internal Career Opportunities portal in Workday.