Regulatory Strategist - Associate Director
Company: Sanofi
Location: Bridgewater
Posted on: May 9, 2024
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) preferredExperience/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-SAPDNAt 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, New Rochelle , Regulatory Strategist - Associate Director, Executive , Bridgewater, New York
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