4 Global Regulatory Affairs CMC Lead, Influenza Jobs in Bridgewater, NJ
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Global Regulatory Affairs CMC Lead, Influenza
$83k-109k (estimate)
Full Time | Pharmaceutical
1 Week Ago
Sanofi is Hiring a Global Regulatory Affairs CMC Lead, Influenza Near Bridgewater, NJ
Job title:
Main responsibilities:
#GD-SP
Pursue progress, discover extraordinaryBetter 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, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
- Location: Swiftwater, PA or Bridgewater/Morristown, NJ
Main responsibilities:
- As the Global Regulatory Affairs CMC Lead for Influenza, you will be responsible for the management and leadership of the regulatory aspects of influenza team.
- Develop global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, and/or vaccine products) in collaboration with other parts of Global Regulatory Affairs.
- Interpret global regulations & appropriately apply, implement, and communicate regulation, established or draft guidance's. Identify/recommend changes in regulations to strengthen company business approaches.
- Provide leadership, regulatory expertise, regulatory strategy, and regulatory influence on projects and teams.
- Identify regulatory opportunity and risk. Anticipate and communicate possible regulatory paradigm shifts that impact the company.
- Identify, communicate, and manage resolution to regulatory CMC issues. Articulate the implication of issue to project team risk/benefit strategic component, ensuring consistency in approach.
- Assures that appropriate contacts with Health Authorities, in collaboration with Country Regulatory Groups, are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships.
- Responsible for direct contact/liaison with US FDA and EMA on specific CMC topics. Supports strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS).
- Contributes knowledge and expertise on GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, in order to assure that appropriate Sanofi visibility and input is recognized.
- Monitors the review of local and international Health Authority regulations and guidelines, contributes to the commenting process and/or develops position papers. Ensures that current Health Authority thinking and trends (paradigm shifts) are understood and broadly communicated.
- Five or more years managing an influenza portfolio
- Demonstrated experience managing people and teams
- Established Health Authority experience (US/Global)
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- 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 and at least 14 weeks’ gender-neutral parental leave.
#GD-SP
Pursue progress, discover extraordinaryBetter 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, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$83k-109k (estimate)
POST DATE
06/21/2024
EXPIRATION DATE
07/14/2024
WEBSITE
sanofi.us
HEADQUARTERS
RIDGEFIELD, NJ
SIZE
15,000 - 50,000
FOUNDED
1972
TYPE
Product/Brand/Service
CEO
ELAINE O'HARA
REVENUE
$1B - $3B
INDUSTRY
Pharmaceutical
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