Regulatory Strategist Senior Manager / Associate Director Vaccines
Company: Sanofi
Location: Swiftwater
Posted on: November 20, 2023
Job Description:
Job title: Regulatory Strategist (RS)
- Grade: (only for internal Job description)
- Hiring Manager: Global Regulatory Lead
- Location: multiple locations
- % Remote working and % of travel expected : NA
- Job type: Permanent, Full time Please note that this is a
generic description of roles and competencies, some agility is
required in reading and application About the job Our Team:The team
is involved in developing regulatory product strategies for the
therapeutic area, leading regulatory efforts in the development
stage and post marketing of drug products.Main responsibilities:-
As a key member of the Global Regulatory Team (GRT), and strategic
partner to the Global Regulatory Lead (GRL), the RS 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 Global Regulatory Team (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
- 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.
- Ensures 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
- Ensures 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.
- Supports operational and compliance activities for assigned
deliverables, develops, executes regulatory submission planning
activities, including generating submission content plans,
submission tracking, and document management.
- Accountable for complete and accurate communication/interaction
(including tracking) with the relevant HAs for the
projects/products in their remit. About you Knowledge, Skills &
Competencies: (Minimum required)
- Proactively contribute with curiosity and openness to diverse
perspectives
- Emerging understanding of clinical development of drugs and/or
novel biologics products
- Demonstrates business acumen, leadership, influencing and
negotiation skills
- Effective communication skills, specifically strong oral and
written presentation skills preferred
- Ability to work in electronic document management systems,
e.g., Veeva vault is a plus
- Demonstrated ability to handle multiple projects/deliverables
simultaneously is preferred
- Strong sensitivity for a multicultural/multinational
environment.Experience & Education: (Minimum required) BS/BA degree
in a relevant scientific discipline or MSc in Biology, Life
Science, or related field with at least 5 years of relevant
pharmaceutical/biotechnology industry experience, including at
least 3 years of relevant Regulatory Affairs experience or Advanced
degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory
or relevant pharmaceutical/biotechnology industry experience
required Pursue progress, discover extraordinary Better 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, color, ancestry, religion, sex, national
origin, sexual orientation, age, citizenship, marital status,
disability, or gender identity.Watch our ALL IN video and check out
our Diversity Equity and Inclusion actions at !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
all.
Keywords: Sanofi, Scranton , Regulatory Strategist Senior Manager / Associate Director Vaccines, Executive , Swiftwater, Pennsylvania
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