Director Regulatory Science & Policy, NA
Posted on: November 17, 2019
Sanofi ? Director Regulatory Science & Policy, NAJob
DescriptionRole:Lead and support Sanofi activities in global
regulatory science and policy (GRSP).? Reporting through Global
Regulatory Affairs (GRA), the candidate will work collaboratively
with both internal and external stakeholders to identify areas
important to the Sanofi and pharmaceutical business, advise
internal stakeholders on the evolving regulatory policy issues, and
influence the developing external regulatory landscape and for
internal product development. ?Responsibilities:
- Monitor emerging regulatory policy issues in assigned areas,
including issues arising from North American regulatory
authorities, legislatures, within the pharmaceutical industry or
elsewhere, and identify those issues likely to impact Sanofi?s
R&D pipeline, regulatory strategy or product portfolio.? While
assigned areas may change, initial assignments will focus on North
American regulatory policy related to CMC, biosimilars and
generics, and combination products.?
- Provide regulatory intelligence to internal stakeholders,
including GRA, R&D, Government Affairs, Medical Affairs and
Legal. Effectively communicate impact and bring awareness of
business critical issues for informed decision making, and work
with subject matter experts within the company to assess impact on
Sanofi?s products and goals.
- Coordinate and lead internal teams to develop Sanofi responses
and comments on draft legislation, regulations, guidelines and
regulatory policies issues.? Liaise closely with colleagues
(R&D, External Affairs, etc.) leading policy activities in the
external environment to facilitate regulatory input and overall
alignment on Sanofi position. Plan and manage interactions and
communications with trade associations and health authorities on
regulatory policy matters.
- Lead proactive advocacy efforts for Sanofi?s priority
regulatory policy areas.? Consult with internal experts and
leadership to identify priority issues.? In collaboration with GRSP
team, internal experts and stakeholders, coordinate company policy
positions across stakeholder groups, identify or create
opportunities for engagement with regulatory authorities and trade
associations, and execute on proposed strategies.?
- Serve as key liaison, and represent Sanofi as assigned, with
trade associations, think tanks, advocacy organizations and
regulatory authorities, managing and guiding the strategy for and
execution of these interactions.
- Provide support and leadership on additional projects
concerning the development, status and impact of regulatory policy
issues.? Produce regulatory intelligence reports or deliverables as
it relates to project or process strategies to further regulatory
strategy and decision-making. Prepare and deliver regulatory
intelligence alerts, summaries, reports and newsletters on regular
schedule highlighting pertinent regulatory activities and potential
impact on Sanofi products and businesses.
- Maintain consistent oversight of deliverables and ensure issues
are escalated when needed and encourage resolution at the
- Play a key role in development and implementation of
appropriate systems, processes and standards within Regulatory
Science and Policy and within GRA and Sanofi as assigned.
- Act consistently with Sanofi best practices and code of
ethics.Experience and skills:
- Advanced degree in life sciences, or law; or equivalent
experience in pharmaceutical industry or science policy.
- 12+ years of experience including 8 years in the pharmaceutical
industry, either within government, industry, or consultants.
?Extensive and proven expertise in healthcare regulatory
- Familiarity and understanding of the drug/biologic development
and commercialization process.
- Previous experience working with senior-level members or
officials of trade associations or other key groups that influence
- Existing relationship with local/regional government
legislators, committees, administrative staff or other key parties
- Impeccable ethics and proven ability to demonstrate Sanofi
- Proven leadership skills. Self-motivated, prone to action and
results oriented. Provides an engaging and motivating work
- Ability to lead multiple complex initiatives (short, mid and
long-term). Superior time management and organizational
- Excellent business acumen and strategic agility. Critical
thinker. Good judgment and decision making abilities.
- Outstanding interpersonal and communication/presentation
- Strong influencing and negotiation skills.Sanofi Inc. and its
U.S. affiliates are Equal Opportunity and Affirmative Action
employers committed to a culturally diverse workforce. All
qualified applicants will receive consideration for employment
without regard to race; color; creed; religion; national origin;
age; ancestry; nationality; marital, domestic partnership or civil
union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military
status or liability for military status; domestic violence victim
status; atypical cellular or blood trait; genetic information
(including the refusal to submit to genetic testing) or any other
characteristic protected by law.#GD-SA#LI-SAAt Sanofi diversity and
inclusion is foundational to how we operate and embedded in our
Core Values. We recognize to truly tap into the richness diversity
brings we must lead with inclusion and have a workplace where those
differences can thrive and be leveraged to empower the lives of our
colleagues, patients and customers. We respect and celebrate the
diversity of our people, their backgrounds and experiences and
provide equal opportunity for all.
Keywords: SANOFI, Germantown , Director Regulatory Science & Policy, NA, Executive , Bethesda, Maryland
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