Regulatory Strategist - Associate Director
Company: Sanofi
Location: Bridgewater
Posted on: April 28, 2024
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Job Description:
Main responsibilities: Leads the US regulatory activities. As a
key member of the Global Regulatory Team (GRT), and strategic
partner to the Global Regulatory Lead (GRL), the Regulatory
Specialist leverages their regulatory expertise to contribute to
the definition of the global regulatory strategy, to enable and
drive the execution of aligned US, EU and/or global regulatory
strategy for assigned projects, including Health Authority
interactions. The Regulatory strategist provides regulatory
expertise and guidance on procedural and documentation requirements
to GRT and cross-functional teams working flexibly within and
across regions to ensure the delivery of business objectives.
Enables the GRL by providing quality regulatory input and position
to internal business partners, including but not limited to the
clinical development teams, commercial and Global Regulatory Team
for assigned projects Liaises with clinical, commercial, and other
internal business partners in partnership with the GRL to enable
successful regulatory outcomes Contributes to the development of a
harmonized, One Sanofi regulatory voice through participation in
appropriate committees, forums at the direction of the GRL
Contributes to the GRT for assigned projects in alignment with the
team's one regulatory voice for providing strategic input on the
TPP, business planning, governance, and committees. May be
requested to lead Global Regulatory Team meetings May represent GRT
strategic position on behalf of the GRL at regulatory
forums/committees at request of GRL ((e.g. clinical study team
meetings) May serve as a regional/local regulatory lead and point
of contact with Health Authorities for projects/products in their
remit, as needed Identifies regulatory risks and proposes
mitigations in collaboration with the GRL, to cross-functional
teams working with Sanofi standardized methodologies as appropriate
Contributes to the development of Global Regulatory Project
Strategy (GRPS) and ensures alignment with the core product
labeling for products in development as well as for life cycle
management of products Participates in the development and
monitoring of the global regulatory environment and updating of
standards and processes related to drug and biologics regulations
Ensure that respective regulatory team members have the information
necessary to contribute to the development and execution of the
Global Regulatory Strategy for their responsible accountabilities
May contribute to the development of global HA interaction strategy
in collaboration with non-US - non-EU regions / GRA-CMC /
GRA-Devices. Attends HA meetings and collaborates with the regions
/ GRA-CMC /GRA-Devices to communicate the outcome to senior
management as needed May lead Health Authority meetings and
preparations as designated Leads submission team or regulatory sub
team to ensure NDA/BLA/ MAA/Extensions filings meet the project
timelines for product launch and is responsible for the development
and update of the core global dossier / collaborates with regional
lead where region-specific submissions are applicable Leads the
IND/ CTA submission strategy to ensure preparation timelines meet
the project timelines for clinical trial initiation Ensure that
regulatory messaging for regulatory submission documents is aligned
with program level and company objectives Contributes to content
and reviews regulated documents (such as IB, PBRER, DSUR, RMP, etc)
Accountable for developing the Health Authority engagement and
interaction plans for their assigned products, including the
authoring of the briefing document focused on the strategy and
scientific content, leading the team through meeting preparations
and moderating the meeting itself for the projects in their remit.
Supports operational and compliance activities for assigned
deliverables, develops, executes regulatory submission planning
activities, including generating submission content plans,
submission tracking, and document management utilizing the support
and input of cross-functional team and/or alliance partners where
relevant . Accountable for complete and accurate
communication/interaction (including tracking) with the relevant
HAs for the projects/products in their remit. Education: 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) preferred Experience/Professional requirements: US
regulatory expertise in pre-marketing/development activities
required At least 6 years of prior pharmaceutical/biotechnology
industry experience, including at least 4 years of relevant
Regulatory Affairs experience (regionally and/or global) especially
in development phase Demonstrated experience with preparation of
(s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing
documents and negotiating with a national/regional Health Authority
preferred . Knowledge, Skills & Competencies: Proactively
contribute with curiosity and openness to diverse perspectives
Understanding of clinical development of drugs and/or innovative
biologics products Demonstrated significant leadership experience
with driving the preparation of regulatory documents (e.g.
(s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing
documents) and negotiating with a national/regional Health
Authority Emerging business acumen, leadership, influencing and
negotiation skills Ability to use appropriate interpersonal styles
and techniques to build internal and external networks and lead
discussions with internal and external stakeholders. Effective
communication skills, specifically strong oral and written
presentation skills Lead operational and compliance activities for
assigned deliverables, develop, execute and maintain including
generating submission content plans, submission tracking, and
document management utilizing the support and input of
cross-functional team and/or alliance partners where relevant
Experience working in and strong knowledge of electronic document
management systems (e.g. Veeva vault, Plai) Demonstrated ability to
handle multiple projects/deliverables simultaneously Strong
sensitivity for a multicultural/multinational 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-SA PDN At 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, Perth Amboy , Regulatory Strategist - Associate Director, Executive , Bridgewater, New Jersey
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