Regulatory Policy & Intelligence Lead (EUCAN):応募後で応募 求人ID R0020589 掲載日 06/15/2020 Location:Zurich, Switzerland
Director, Regulatory Policy & Intelligence Lead (EUCAN):
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our Regulatory Policy & Intelligence Lead (EUCAN), at Director level in our office in Zurich, Switzerland.
- Works with external contacts including Regulatory Authorities, professional scientific and regulatory groups, trade associations and consultants to influence the external regulatory in support of Takeda’s portfolio.
- Provides expertise as lead interface with regulatory Authorities when negotiating business critical issues.
- Understands interfaces across Takeda, for instance with other R&D Functions, Strategic Planning and Program Management, Supply Chain and Quality Assurance, Legal, Finance, Investor Relations, Corporate Communications.
- As a member of the EUCAN Reg. Affairs leadership team, provides leadership and input to the development and implementation of the strategic direction of the EUCAN Regulatory Affairs group. Constantly strives to be ahead of the curve by focusing on Takeda’s Mission and strategy principles.
- Represent Takeda with the external environment managing and influencing regulatory policy challenges.
- Shape the regulatory policy environment in line with Takedas goals and objectives.
- Ensure that important and relevant regulatory information is assessed for impact and communicated to key internal and external stakeholders to support shaping the direction and outcome of such changes.
- Effectively evaluates data to identify regulatory trends and educates internal stakeholders on these trends.
- Working with regulatory staff, monitors, identifies, analyzes, and disseminates intelligence on important global regulatory agency changes. Represents Takeda on industry regulatory working groups and policy initiatives impacting Takeda’s business or development programs.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
- Master’s or doctorate degree or equivalent in pharmacy, chemistry, biology or related science field preferred.
- Generally has at least 10+ years of related pharmaceutical experience or equivalent combination of education and experience or or a combination of 10 years of regulatory and/or related experience in both development and post-marketing phases
- EU experience required
- Thorough Knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the EU and Canada. Sound knowledge of intelligence tools and methods
- Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy and strategy for the region. Proven track record working with a major regulatory agency, specific experience in government affairs or policy is also desired
- Direct experience in the pharmaceutical industry or related field required
- Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.
What Takeda Can Offer You
To further support and inspire our employees, our benefits include: Competitive basic salary, Annual Bonus, Long-Term Incentive Plan, Car Allowance, Contributory Pension Scheme, Private Health Cover and Life Assurance.
Empowering Our People to Shine
Learn more at takedajobs.com