(Director) Global Regulatory Team Lead - Vaccine
Company: Principia Biopharma Inc.
Posted on: January 16, 2022
The Global Regulatory Team Lead (GRTL) within the Sanofi Pasteur
Global Regulatory Affairs (GRA) organization is accountable for
developing and executing robust global regulatory strategies for
pipeline and lifecycle assets to ensure achievement of global
regulatory/business objectives of Sanofi's Vaccines Global Business
Unit. The GRTL leads and prospectively works with the Global
Regulatory Team (GRT) and works with and participates on
multi-disciplinary matrixed project/product teams to successfully
meet project deliverables. The GRTL reports to the GRA Influenza
and RSV franchise lead and is responsible of some Influenza
vaccines of the portfolio.
Represents Global Regulatory Affairs (GRA) as a member of the cross
functional project/product team and/or Brand team. In this
capacity, the GRTL is the single point of contact for the business
and R&D on regulatory issues for the project. The GRTL provides
regulatory advice and strategy for the project(s)/products and
ensures timely execution of regulatory activities.
Leads the GRT (RA regions, Regulatory CMC, Regulatory Operations,
Regulatory labeling). Ensures effective communication between cross
functional project team and the GRT; oversees planning and
execution of global regulatory activities and submissions.
Ensure development of robust global regulatory strategies for the
projects/products and is accountable for developing and maintaining
a regulatory strategy document (GRPS). The regulatory strategy
addresses the Target Product Profile, regional specific needs,
regulatory environment, regulatory risks and mitigations, global
submission strategies, and reimbursement strategies as well as life
product cycle management strategy. The GRTL will work with the GRT
to ensure relevant input from all GRA functions is vetted and
included in the regulatory strategy framework.
Responsible for developing regulatory strategy information for
presentation during leadership governance meetings. The GRTL is
accountable for ensuring GRA Sr. Management alignment with
strategy, risks and mitigation and for presenting a unified
The GRTL is responsible for ensuring communications from HAs and
meetings with HA are fully supported and that minutes are
disseminated in a timely manner and properly interpreted, to the
project/product teams, the business unit, and GRA Sr.
- Provide regulatory due diligence assessments of new business
opportunities as required.
- 7-10 years pharmaceutical industry experience in R&D,
Regulatory or related functions, with at least 5 years working in
regulatory affairs (regionally or globally). Regulatory lead
experience in US or EU. BA/BS in a scientific discipline or related
field of study.
Advanced degree preferred.
Experience with least one major marketing application
(NDA/BLA/MAA/JNDA etc.), or extensive experience with late stage
- Licensed product knowledge and experience with post-approval
changes is also desired.
Knowledge, Skills and Other Experience:
Solid knowledge and understanding of complex medical and scientific
subject matter as well as evolving regulatory policy and
Experience / Exposure to vaccines is desired.
Direct interaction/negotiation with regulatory authorities (e.g.
FDA, EMA, BRDD).
Strong strategic skills including the ability to make complex
decisions and willingness to defend difficult positions.
Excellent operational skills including planning, organizing and
ability to motivate and lead others.
Ability to work well within cross-functional teams.
Can demonstrate solid oral communication and writing skills.
Understanding of the Global pharmaceutical market place and
familiarity with medical terminology. Understands issues, problems,
and opportunities by comparing data from different sources to draw
conclusions and then can choose a course of action or develop the
Develops collaborative relationships to facilitate the
accomplishment of work goals.
Generates innovative solutions in work situations, trying different
and novel ways to deal with work problems and opportunities.
Shows ability to use appropriate interpersonal styles and
techniques and can modify behavior to gain acceptance of ideas or
Can build networks to obtain cooperation without relying on
Strong sensitivity for a multicultural/multinational
- Unquestionable ethics, professional integrity, and personal
values consistent with the Sanofi.
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.
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
Keywords: Principia Biopharma Inc., Cambridge , (Director) Global Regulatory Team Lead - Vaccine, Executive , Cambridge, Massachusetts
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