HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
EXECUTIVE DIRECTOR, REGULATORY EUROPEAN THERAPEUTIC AREA HEAD
What you will do
As a key senior leader in the ELMAC (Europe, Latin America, Middle East & Africa, and Canada) Regulatory Leadership Team you will contribute to the successful running of the ELMAC Regulatory Department.
This strategic product facing leadership role leads a team of staff that develop and execute innovative European regulatory strategies across the General Medicine portfolio of developmental and commercialized products in the areas of Inflammation, Cardio-Metabolic, Neuroscience, Bone, Endocrine, Haematology (Non-Oncology), Nephrology and Biosimilars.
Key responsibilities include:
Strategy and Execution
- Support and influence the development of innovative, robust European regulatory strategies that will enable the future success of the Amgen product portfolio.
- Direct the development of European regulatory strategy across the therapeutic area and provides oversight of key European regulatory decisions within a therapeutic area
- Advise the EU Regulatory Lead (EURL) in the development of regulatory strategies, including precedence, risk management and contingency planning
- Conduct management review and approval of European Regulatory Strategic Plan and key documents for regulatory submissions
- Participate and represent Europe at the Regulatory Strategy forums (eg GRAC) and ad hoc alongside the Global TA Head at Global Commercialization forums as necessary
- Partner with the Global TA head to understand the future direction of the Therapeutic Area and the context for the product strategies.
- Collaborate with the European country regulatory Network to ensure future local success.
Ensure that the external regulatory environment is being interpreted to optimize regulatory outcomes
Health Authority Interactions
- Advise and directs EURL on regulatory agency interaction strategies
- Oversee EMA engagement within assigned area
- Interact and negotiate with key regulatory agency officials
- Participate on core regulatory and cross-functional teams to ensure effective agency interactions
- Advocate for Amgen/ELMAC GRAAS by building strong relationships with key external stakeholders including senior regulatory agency staff, trade associations, and influential professional bodies.
- Work externally to influence regulatory legislative environment in line with Amgen policy priorities for the therapeutic area
- Participate and represent Amgen GRA on external partnership committees as needed
- Oversee and participate in licensing/acquisition due diligence and other activities in partnership with Amgen Licensing groups
- Monitor, assess, and communicate to staff around the impact of new European regulations and forthcoming changes to the regulatory environment considering risks and opportunities
- Provide direct line management and leadership of a team of regulatory professionals, allowing appropriate prioritization of resources to achieve goals
- Drive continuous improvement by sponsoring new or revised procedures, programmes and initiatives, in partnership with other GRAAS functions and/or with cross-functional stakeholders to ensure we continue to drive operational efficiency and effectiveness.
- Recruit and retain regulatory affairs staff. Support the team to thrive at Amgen, ensuring there are growth and development opportunities (including training, coaching, mentoring). Ensure long term team development, talent management and succession planning.
- Accountable for budget and resource/headcount planning in partnership with the VP, ELMAC Regulatory Affairs
- Represent the Gen Med TA team in ELMAC leadership meetings and as a leader of European Regulatory forums.
- Develop and lead goals for the group
- Exchange regulatory information with Global teams and other regional regulatory colleagues on an ongoing basis and provide advice on ELMAC considerations
- Partner with the EMA therapeutic area regulatory teams to ensure that EU country specific considerations are incorporated into EMA regional regulatory plans
- Provide regulatory expertise to senior management review committees, governance boards, other cross-functional product meetings
- Exchange regulatory information with other Global Regulatory TA Head(s) and Regional Regulatory Heads on an ongoing basis and prior to relevant senior management review committees and governance boards
- Communicate and ensure alignment of functional and cross-functional goals and objectives
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
- Bachelor’s degree in related discipline
- Demonstrated ability in Regional (European and/or International Market) regulatory affairs, supporting & leading teams dealing with complex submissions for both biotechnology and chemically-derived products – this includes products under development and marketed products
- Demonstrated ability to lead and energize teams
- Strong communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Comprehensive understanding of regulatory activities and how they affect projects and processes
- Demonstrable ability to set organizational direction and continuous improvement
- Strong ability to navigate organizational change and serve as a change champion
- Proven ability to anticipate and mitigate against future strategic issues & uncertainties
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across both country and International borders. A champion for Diversity and Inclusion.
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
- Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
LOCATION: This role is expected to be UK-based and Amgen offers flexibility to work from home with a few days per month working from one of our next generation office locations in Cambridge or Uxbridge.
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.