Sanofi Pasteur Inc.

Sanofi Pasteur Inc.

GRA CMC Lead

Toronto, ON · Mid

Sponsorship not specified$109k-$157kDetected 4 days ago
AlgorithmsMachine LearningHRFDA RegulatoryCollaborationRegulatory Affairs

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odds of building a lasting career here

57Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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Employer immigration record

from this employer's Department of Labor filings

Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 5 green-card filings in this occupation, 100% were for a worker who already held the job.

Files H-1B transfers

3 transfer filings in the last year, covering 3 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • You will also be involved in internal or external programs/organizations led by Sanofi and ensure representation of the company by demonstrating the values of Sanofi and Global Regulatory Affairs.
  • About Sanofi We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth.
  • Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world.

Responsibilities

  • Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities.
  • Author the CMC strategy document "Global Regulatory CMC Strategy Document" in connection with the Blue Print model if applicable.
  • If applicable, support the regulatory inspection process.
  • Demonstrate initiative, reflection, foresight and the ability to communicate effectively with internal or external partners.
  • Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.​​

Requirements

  • Knowledge of global regulations/guidelines
  • Ability to solve strategic technical and regulatory problems.
  • You should contact Human Resources if you have a question or concern regarding your personal information.

Nice to have

  • BS/BA degree in a relevant scientific discipline required, e.g., Biology, Chemistry or Life sciences.
  • Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred.
  • Operational experience within an organization (medium to large) in Regulatory CMC department preferred

Compensation

  • 108,900.00 - 157,300.00 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors.
  • 108,900.00 - 157,300.00 La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents.

Benefits

  • Knowledge of global regulations/guidelines; Health Authorities, their modes of operation and their expectations.
  • ​Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs​
  • Ensure that requests from Health Authorities are taken into account in an effective and timely manner.
  • Develop lasting relationships with the Health Authorities.
  • Provide the necessary support for strategic negotiations with the Global Health Authorities, including the FDA (US) and the EMA (Europe), to take pragmatic decisions with the greatest probability of success.
  • Ensure that the requirements of the Health Authorities are taken into account and communicated.

Company info

  • At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
  • Information collected and processed by the Company's Artificial Intelligence systems may include the personal information detailed above and calendar availability.

Visa & Work Authorization

  • ual opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity
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This listing is sourced directly from Sanofi Pasteur Inc.'s careers page and normalized into a canonical job model.