27 Global Regulatory Affairs Lead Jobs in Bridgewater, NJ
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Global Regulatory Affairs Lead
$114k-149k (estimate)
Full Time | Pharmaceutical
1 Month Ago
Sanofi is Hiring a Global Regulatory Affairs Lead Near Bridgewater, NJ
Job title: Global Regulatory Affairs Lead
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities
#GD-SA
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: Cambridge, MA or Bridgewater, NJ
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities
- Accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling in development as well as for life cycle management of products
- Responsible for proactively contributing to the Target Product Profile (TPP), ensuring competitive profiles in alignment with the business objectives
- Is accountable for leading the GRT for fostering team performance by aligning team on mission, prioritization, objectives, and setting clear expectations for the Global Regulatory Strategy and Plan, including a global labeling strategy for assigned projects
- The role will supervise, coach, and facilitate a feedback culture within the GRT to develop team performance
- The GRL is expected to develop a team of Regulatory Strategists (RS) as appropriate
- The GRL is accountable for ensuring alignment and communication internally and externally as “one GRA voice” with TA, GBU Head and up to the GRA LT when needed to advocate regulatory position to governance and committees and shares outcomes to GRT and cross-functional partners as appropriate
- Identify opportunities to support the team to identify regulatory acceleration opportunities, take thoughtful risks, accept challenges, and making final decisions on the regulatory success rates and mitigations on behalf of the GRT
- The GRL is the single GRA point of contact for the program and represents GRA at the GPT / GBT and internal governance committees
- The role is responsible for assessing and interpreting the global regulatory and competitive environments and accountable to ensure that it leverages expertise in commercial competitive intelligence and other parts of GRA (e.g. Regional experts and Regulatory Science and Policy) in order to ensure the most robust strategy possible and is accountable for determining any updates to the regulatory strategy accordingly
- Leads development of global HA interaction plan and strategy in collaboration with GRT. Is accountable for the communication of the key outcomes to senior management
- Advances the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned therapeutic area and projects in collaboration with the Regions
- Accountable for regulatory assessment for Due Diligence activities as applicable through the partnership with GRA Strategy and Business Optimization
- 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) is preferred
- At least 8-10 years of relevant pharmaceutical/biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and global), in early and late stage development of multiple modalities; experience within regulatory CMC not directly applicable
- Demonstrated expert regulatory strategic experience and understanding of the regulatory environment to develop regulatory strategies
- Ability to work strategically within a sophisticated, business critical and high-profile development program
- Experience being accountable for developing and defending innovative regulatory strategies at Global Project Teams or equivalent forum
- Previous experience in leading Health Authority interactions in major markets
- Strategic regulatory leadership expertise with experience in developing and implementing successful regulatory strategy and with preparation of (s)BLA, (s)NDA, or MAA, INDs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority within a major market (e.g. US, EU)
- Experience leading filings/registrations and obtaining a regulatory action in a major market(s)
- Project leadership experience
- Experience leading a team and/or developing internal talent
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
- An individual and well-structured introduction and training when you onboard.
- You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
- As a globally successful and constantly growing company, Sanofi provides international career paths as well.
#GD-SA
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
$114k-149k (estimate)
POST DATE
06/02/2024
EXPIRATION DATE
07/26/2024
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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