Global Regulatory Affairs Lead
Company: Sanofi
Location: Cambridge
Posted on: April 19, 2024
Job Description:
Global Regulatory Affairs Lead (GRL)Mission statements -
- The Global Regulatory Affairs Lead (GRL) is the fully
accountable decision maker for the development & execution of
creative, thoughtful, and robust global regulatory strategies for
their products in Sanofi's diversified portfolio in order to meet
corporate and business objectives. -
- Decisions are made in alignment with the TA, GBU Head and up to
the GRA LT as needed. -
- The GRL is the primary interface and key strategic GRA partner
for the Global Project Team (GPT) and Global Brand Team (GBT).
-Duties & Responsibilities -
- Accountable for leading the development and execution of
innovative and value-added global regulatory strategies and be
responsible for formulating the Global Regulatory Project Strategy
(GRPS), Global Submission Strategy, and core product labeling in
development as well as for life cycle management of products -
- Responsible for proactively contributing to the Target Product
Profile (TPP), ensuring competitive profiles in alignment with the
business objectives -
- Is accountable for leading the GRT for fostering team
performance by aligning team on mission, prioritization,
objectives, and setting clear expectations for the Global
Regulatory Strategy and Plan, including a global labeling strategy
for assigned projects -
- The role will supervise, coach, and facilitate a feedback
culture within the GRT to develop team performance -
- The GRL is expected to develop a team of Regulatory Strategists
(RS) as appropriate -
- The GRL is accountable for ensuring alignment and communication
internally and externally as "one GRA voice" with TA, GBU Head and
up to the GRA LT when needed to advocate regulatory position to
governance and committees and shares outcomes to GRT and
cross-functional partners as appropriate -
- Identify opportunities to support the team to identify
regulatory acceleration opportunities, take thoughtful risks,
accept challenges, and making final decisions on the regulatory
success rates and mitigations on behalf of the GRT -
- The GRL is the single GRA point of contact for the program and
represents GRA at the GPT / GBT and internal governance committees
-
- The role is responsible for assessing and interpreting the
global regulatory and competitive environments and accountable to
ensure that it leverages expertise in commercial competitive
intelligence and other parts of GRA (e.g. Regional experts and
Regulatory Science and Policy) in order to ensure the most robust
strategy possible and is accountable for determining any updates to
the regulatory strategy accordingly - -
- Leads development of global HA interaction plan and strategy in
collaboration with GRT. Is accountable for the communication of the
key outcomes to senior management -
- Advances the organization's goals by participating and taking
leadership roles in professional associations, industry and trade
groups as appropriate for assigned therapeutic area and projects in
collaboration with the Regions -
- Accountable for regulatory assessment for Due Diligence
activities as applicable through the partnership with GRA Strategy
and Business Optimization -Knowledge, Skills & Competencies - -
- Autonomously connects and leverages talent to the advantage of
the greater team, with curiosity and openness to diverse
perspectives -
- Creates a safe environment that inspires creativity,
innovation, and productivity -
- Is accountable for creating forward-looking vision, influences
the environment that optimizes long-term potential by fostering
trust and teamwork - -
- Demonstrates strong business acumen, strong leadership, high
level influence and persuasive negotiation skills -
- Strong scientific acuity applicable to multiple therapeutic
areas - -
- Expert strategic thinker with experience making complex
decisions and defending difficult positions -
- Significant leadership experience in developing innovative
regulatory strategies supporting the clinical development of drugs
and/or innovative biologics products -
- Recognized expert using appropriate interpersonal skills to
build internal networks and autonomously lead complex negotiations
with internal and external stakeholders -
- Exemplary communication skills, specifically excellent oral and
written presentation skills -
- Expert level of organizational savvy; self-motivated and able
to work in a highly matrixed structure including sharing knowledge
with relevant stakeholders -
- Strong sensitivity for a multicultural/multinational
environment -
- Proven leader of groups and teams -Qualifications - -
- BS/BA degree in a relevant scientific discipline required.
Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life
Science, or related field) is preferred -
- At least 10-12 years of relevant pharmaceutical/biotechnology
experience, including at least 10 years of relevant Regulatory
Affairs experience (regionally and global), in early and late stage
development of multiple modalities; experience within regulatory
CMC not directly applicable - - --- - -
- Demonstrated expert regulatory strategic experience and
understanding of the regulatory environment to develop regulatory
strategies -
- Previous experience working on regulatory due diligence
activities and in a business alliance environment -
- Demonstrated experience working strategically within a
sophisticated, business critical and high-profile development
program -
- Direct experience formulating the regulatory position in
collaboration with the GRT and defending innovative regulatory
strategies at Global Project Teams or equivalent forum -
- Extensive experience in leading health authority interactions
in major markets -
- Strategic regulatory leadership expertise with experience in
developing and implementing successful regulatory strategy and with
preparation of at least one (s)BLA, (s)NDA, or MAA, INDs, Health
Authority meeting briefing documents and negotiating with a
national/regional Health Authority within a major market (e.g. US,
EU, CN, JP) -
- Previous demonstrated experience of global regulatory drug
development to at least one major regulatory approval within a
major market (US, EU) including leading the regulatory strategy,
response team, and labeling negotiations -
- Previous experience in leading global Health Authority
interactions -
- Significant project leadership experience -
- Significant experience in managing people both directly or in a
matrixed organizational structure -
- Direct experience with change management/change enabling: leads
teams with a solution-oriented mindset in a fast-changing
organizational and external regulatory environment - -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-SAPursue progress,
discover extraordinaryBetter is out there. Better medications,
better outcomes, better science. But progress doesn't happen
without people - people from different backgrounds, in different
locations, doing different roles, all united by one thing: a desire
to make miracles happen. So, let's be those people.At Sanofi, we
provide equal opportunities to all regardless of race, colour,
ancestry, religion, sex, national origin, sexual orientation, age,
citizenship, marital status, ability or gender identity.Watch our
and check out our Diversity Equity and Inclusion actions at !
Keywords: Sanofi, Waltham , Global Regulatory Affairs Lead, Other , Cambridge, Massachusetts
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