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Regulatory Strategist

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Sanofi

21d ago

  • Job
    Full-time
    Senior Level
  • Science
    Legal
  • Waltham

AI generated summary

  • You need a relevant degree, 5 years in pharma/biotech (3 in Regulatory Affairs), US regulatory expertise, strong communication skills, and experience in diverse, multicultural environments.
  • You will define global regulatory strategy, liaise with cross-functional teams, lead regulatory submissions, interact with health authorities, and ensure compliance for project timelines.

Requirements

  • Knowledge, Skills & Competencies:
  • Proactively contributes with curiosity and openness to diverse perspectives.
  • Understanding of clinical development of drugs, biological products. Vaccines is a plus.
  • Demonstrates business acumen, leadership, influencing and negotiation skills.
  • Effective communication skills, specifically strong oral and written presentation skills.
  • Ability to work in electronic document management systems, e.g., Veeva Vault is a plus.
  • Demonstrated ability to handle multiple products/deliverables simultaneously.
  • Strong sensitivity for a multicultural/multinational environment.
  • Experience & Education:
  • 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.
  • Significant US regulatory expertise required.

Responsibilities

  • As a key member of the Global Regulatory Team, the Regulatory Strategist (RS) is the strategic partner to contribute to the definition of the global regulatory strategy for assigned product, to enable and drive its execution in US, EU and worldwide countries, including Health Authority interactions.
  • The RS provides regulatory expertise to the Global Regulatory Team and cross-functional teams to ensure the delivery of business objectives.
  • The RS enables the Global Regulatory Lead (GRL) to provide regulatory position to support business needs, as well as the regulatory team members to provide the necessary information for their responsible accountabilities.
  • The RS liaises with clinical, medical, commercial, supply functions, and other internal business stakeholders to enable successful regulatory outcomes.
  • The RS contributes to the development of a harmonized, regulatory voice for providing strategic input through participation in appropriate governance committees and forums at the direction of the GRL.
  • The RS may represent Global Regulatory Team strategic position on behalf of the GRL at regulatory forums/committees at request of GRL.
  • The RS serves as point of contact with Health Authorities for vaccines in his/her remit in US.
  • The RS contributes to the development of global Health Authorities interaction strategy in collaboration with the regulatory team members, attends and may lead Health Authorities meetings, and leads the team through meeting preparations.
  • The RS may lead submission team or regulatory sub team to ensure regulatory filings meet the project timelines for product launch.
  • The RS leads the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation.
  • The RS contributes to content and reviews regulated documents (such as clinical protocol, IB, DSUR, RMP, etc.)
  • The RS supports operational and compliance activities for assigned regulatory deliverables and develops regulatory submission planning, including submission tracking in the electronic document management system.

FAQs

What is the primary focus of the Regulatory Strategist position at Sanofi?

The primary focus of the Regulatory Strategist position is to develop and execute regulatory strategy for a new vaccine asset aimed at protecting toddlers against RSV disease, as part of the Flu/Respiratory Syncytial Virus Franchise.

Where is the Regulatory Strategist position located?

The position is located in Bridgewater, NJ; Cambridge, MA; or Swiftwater, PA.

What qualifications are required for the Regulatory Strategist role?

A BS/BA degree in a relevant scientific discipline or an MSc in Biology, Life Science, or a related field with at least 5 years of relevant experience, including at least 3 years in Regulatory Affairs, or an advanced degree (PharmD, PhD, MD, or DVM) with at least 2 years of regulatory experience is required.

What experience in regulatory affairs is necessary for this position?

Significant expertise in US regulatory affairs is required.

What are the main responsibilities of the Regulatory Strategist?

The main responsibilities include contributing to the definition and execution of global regulatory strategy, liaising with various internal stakeholders, contributing to Health Authority interaction strategies, leading submission teams, and supporting operational and compliance activities for regulatory deliverables.

What skills are important for a Regulatory Strategist at Sanofi?

Important skills include effective communication, business acumen, leadership, influencing and negotiation skills, and the ability to handle multiple products/deliverables simultaneously.

Is there an emphasis on teamwork in this role?

Yes, the role requires collaboration with cross-functional teams, including clinical, medical, and commercial, to ensure successful regulatory outcomes.

What kind of company culture does Sanofi promote?

Sanofi promotes a supportive, innovative, and diverse company culture that encourages professional growth and values contributions from employees.

Are there opportunities for career advancement within Sanofi?

Yes, Sanofi offers numerous opportunities for employees to grow their talent and advance their careers through promotions or lateral moves.

Does Sanofi offer health and well-being benefits?

Yes, Sanofi provides a wide range of health and well-being benefits, including high-quality healthcare, prevention, and wellness programs.

Sanofi

Science & Healthcare
Industry
10,001+
Employees
2004
Founded Year

Mission & Purpose

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.