International Regulatory Affairs: Head of ACE (Australia/Canada/Europe)
International Regulatory Affairs: Head of ACE (Australia/Canada/Europe) Affiliates- Flexible location
United Kingdom - Uxbridge
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
The impossible is not impossible.
It's simply what hasn't been achieved yet.
Creating Possible drives everything we do. It's evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving the lives of people around the world and advancing the care of patients suffering from life-threatening diseases.
Head of Regulatory ACE Affiliates
This is an exciting opportunity for a new Head of Regulatory Affairs Affiliates. The role will have oversight of all of our ACE (Australia Canada Europe) affiliates, including our core markets (France, Germany, Spain, UK, Italy & Canada).
This role will lead teams responsible for securing and maintaining regulatory activities in ACE markets. It will provide strategic direction, oversight, synergy and alignment with company processes and ensuring compliance for all Regulatory Affairs in these markets. This position will support product development projects and commercialized products and collaborate with key suppliers to ensure regulatory requirements are met. The position will ensure deployment of processes for effective GDP/GMP as part of the Quality Management System.
We are looking for a unique individual who is passionate about advancing therapeutics with creative problem-solving skills to seamlessly meet business needs while maintaining regulatory compliance.
Leading a team of Senior Regulatory professionals, the successful candidate will have extensive experience in managing and guiding large teams to success.
The incumbent will join the International Regulatory Affairs Leadership Team and the ACE Commercial Leadership Team (ACE CLT) with the core 6 countries
Essential Duties and Responsibilities include the following:
- Accountable for the overall management of the ACE Regulatory Affairs Teams including organization design, performance management, budgeting and execution of strategic and operational objectives.
- Develop strategies and lead teams to support Clinical Trials, Advertising and Promotions, Early Access Programs, GDP/GMP licenses.
- Assess and develop strategies to mitigate regulatory challenges associated with product development and maintenance of marketing authorisations in ACE markets
- Oversee all regulatory activities in ACE markets including development and maintenance of procedures to ensure regulatory compliance in line with GxP.
- Drive opportunities to streamline processes and build organizational alignment when leading specific RA departmental initiatives.
- Develop employees to maximize their potential
Background & Experience:
- Extensive experience in the pharmaceutical/biotechnology industry in Regional roles
- Extensive knowledge of regulatory requirements, including ICH requirements and regional requirements and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business.
- Experience in developing and implementing regulatory strategies and of managing complex negotiations with regulatory authorities.
- Experience in taking a leadership role in updating and preparing the Company for major changes in legislation which impact many departments.
- Experience in critically reviewing complex technical documents and influencing colleagues across functions.
- Should have a science degree (PhD, PharmD, MD, MSc)
- Experienced people manager, with an exceptional ability to lead team members successfully.
Skills & Behaviors
- Self-motivator, enthusiastic, tenacious and energizing.
- Proactive and open to share, advise and coach colleagues.
- Agile in an evolving environment.
- Resilient with the ability to influence and deliver in an ambiguous environment.
- Ability to engage stakeholders and manage multiple stakeholders to achieve the objective.
- Excellent leadership, planning and organisational skills
- Excellent verbal & written English, negotiation, influence and interpersonal communication skills
Gilead Core Values
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
- I AM BOLD in aspiration and AGILE in execution.
- I CARE and make time for people.
- I LISTEN, speak openly and explain the "why."
- I TRUST others and myself to make sound decisions.
- I OWN the impact of my words and actions.
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.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-Kingdom---Uxbridge/International-Regulatory-Affairs--Head-of-ACE--Australia-Canada-Europe--Affiliates--Flexible-location_R0017298-1
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