Regulatory Affairs Leader - Strategy & Submissions
G&L Scientific
G&L Scientific Ltd is seeking an experienced Senior Manager or Director of Regulatory Affairs to join our team in Madison, New Jersey. This role involves providing strategic regulatory guidance across various client engagements, leading regulatory submissions, and interacting with agencies like the FDA. The ideal candidate has 7-10 years of US regulatory experience, strong client leadership skills, and the ability to operate on both strategic and operational levels. Join us to make an impactful contribution to client development strategies. #J-18808-Ljbffr
- Sanofi is seeking a Global Submission Lead to oversee regulatory submission planning and coordination. This role involves ensuring that all submissions meet regulatory standards and are delivered on time. The successful candidate will collaborate across teams and manage...Suggested
- ...biopharmaceutical company is looking for an Associate Director of Regulatory Affairs to lead the regulatory strategies for Chemistry, Manufacturing, and Controls (CMC). You will prepare and manage regulatory submissions while collaborating with internal departments to ensure...Suggested
$215k - $295k
Shionogi Inc. is seeking a Director/Senior Director of COA Strategy in Florham Park, NJ. This role focuses on developing COA strategies... ...providing leadership to cross-functional teams, and ensuring regulatory acceptability of endpoints. The ideal candidate will possess a...Suggested- ...products. The role requires significant experience in Medical Affairs and knowledge of Pulmonary and/or Immunology. The ideal candidate... ...sciences and have a proven track record in executing medical strategies. The position offers health and wellbeing benefits, including...Suggested
$178.5k - $257.83k
Job title: Global Regulatory Lead Location: Morristown, NJ / Cambridge... ...on our Global Regulatory Affairs, Oncology Team, you’ll be fully... ...robust global regulatory strategies for their products in Sanofi... ...Project Strategy (GRPS), Global Submission Strategy, and core product...Suggested$95k - $125k
...Senior Workplace Strategist Workplace Strategy at Gensler is focused on enabling... ...As a business developer and thought leader you'll Support the development of... ...examples and a cover letter as part of your submission About Strategy at Gensler Gensler'...Full timeWork at officeLocal area$114.1k - $211.9k
...seeking a Senior Manager, Qualification in Morris Plains, NJ. This pivotal leadership role involves overseeing site qualification strategies for equipment and computerized systems within pharmaceutical operations. The ideal candidate will need at least 7 years of...$124.1k - $175.2k
...seeking a Manager, Club Insights & Business Intelligence who will lead market research and analytics initiatives to drive sales strategies for Sam’s Club and Costco. The ideal candidate has 6-8 years in business intelligence, strong analytical skills, and excellent communication...$236.6k
...Novartis Farmacéutica is seeking an Executive Director, Product Strategy Lead (PSL) to spearhead integrated product strategies at the East Hanover, NJ site. This role involves crucial engagement across multiple functions, aiming to enhance the product's impact and manage...$236.6k
...looking for an Executive Director, Marketing Strategist in East Hanover, NJ. This significant role will spearhead global marketing strategies and oversee brand performance within neuromuscular and rare diseases. The ideal candidate will have over 10 years of experience...- Job title: Global Submission Lead Location Morristown, NJ / Cambridge... ..., and tracking of regulatory Priority portfolio and Integration... ...implementation of e-Submission strategies between two companies.... ...or equivalent, in regulatory affairs, life sciences, or related areas...WorldwideFlexible hours
- Allergan seeks an Associate Director for US Market Access to lead the VRAYLAR Integrated Access Strategy, ensuring alignment across commercial and Medicare contracting efforts. The ideal candidate will possess a Bachelor's degree, 5+ years of experience in market access...
- AbbVie is looking for a strategic leader in US Market Access to join their Florham Park, NJ team. The role emphasizes generating insights... ...closely with executive leadership to optimize AbbVie’s market strategies. A strong background in pharmaceutical market access and...
- BioSpace is looking for a Global Regulatory Lead to oversee regulatory strategy for oncology products. The role involves collaboration with project teams... ...candidate will have extensive experience in regulatory affairs, particularly in oncology, and a strong ability to...
$236.6k
Novartis Group Companies in East Hanover, NJ is seeking an Executive Director, Product Strategy Lead. You will spearhead product strategy development and execution while contributing to key decision-making regarding product impact and resource allocation. Ideal candidates...- ...New Jersey, is seeking a Principal Specialist, Global Labeling Regulatory to oversee product labeling compliance throughout its... ...The role will require leadership in developing global labeling strategies while ensuring they meet regulatory requirements. The ideal candidate...
$240.94k - $291.96k
...working-with-us . Director, US Regulatory Lead, GRS Position... ...USRL) will oversee regulatory strategy and execution for Immunology... ...including upcoming NDA submission. The incumbent may also serve... ...Significant experience in regulatory affairs (e.g. 4-7 years), with at...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$215k - $240k
...the future of dermatology by driving regulatory strategy for LEO Pharma's most exciting early-stage... ...Serve as the primary U.S. Regulatory Affairs representative for assigned early-... ...the coordinated preparation and timely submission and approval of regulatory filings (e....Permanent employmentContract workWork at officeLocal area- ...Lumanity is looking for a VP/SVP, Patient Strategy to drive patient engagement strategy and support client relationships. This senior-level role requires at least 15 years of experience in life sciences, strong leadership abilities, and financial expertise. The successful...Flexible hours
- Novartis Farmacéutica in East Hanover, NJ, is seeking an Associate Director, Marketing Strategy to shape a breakthrough therapy launch. You will define and drive the brand's marketing strategy and work with cross-functional partners to ensure successful execution. The...
$152.6k - $283.4k
Legend Biotech USA is looking for an Associate Director of Marketing Strategy located in East Hanover, NJ, or Cambridge, MA. This role involves driving launch strategies for a priority brand in the neuromuscular rare disease community. The ideal candidate will have at...- ...and HTA, and serves as the brand/asset leader representing HEOR on cross functional asset... ...are reflected in the overall asset strategy. He or she may be accountable for more... ...support. Extensive knowledge of the global regulatory, HTA and PR&A landscape, as well as...Temporary workWork experience placementLocal area
- Zoetis Spain SL is seeking a strategic leader in Parsippany-Troy Hills, NJ, to drive major global strategic initiatives impacting the... ...departments. Ideal candidates should have a strong background in strategy consulting or finance, with a Bachelor’s degree required and an...
- ...Therapeutics, Inc. is seeking a Global Regulatory Strategist in Morristown, NJ to develop regulatory strategies in oncology. This role... ...teams and ensuring timely submissions to Health Authorities. The ideal... ...experience in Regulatory Affairs and a deep understanding of clinical...
$160k - $195k
...We are seeking a Transportation Group Leader with established client relationships for... ...best practices and continuous improvement strategies in engineering processes. * Technical... ...candidates and employee referrals. The submission of unsolicited resumes by recruitment or...Work at officeLocal area- ...Kenvue-1 is looking for a Senior Manager, HCP Pediatrics Strategy & Growth to lead long-term growth for Kenvue’s pediatric HCP business across several brands including Aveeno Baby and Children’s Tylenol. This hybrid role involves shaping strategic growth, partnering with...
$210k - $303.33k
...Job title: Finance Strategy and Cross-Organization Excellence Lead Location: Cambridge, MA or Morristown, NJ About the job... ...strategic risks and opportunities — including competitive threats, regulatory shifts, and macroeconomic trends — and translate them into...Immediate startShift work- ...WD-40 Company in Pine Brook, NJ, is seeking a leader for its global regulatory compliance strategy. This role requires 10-15 years of regulatory compliance experience, particularly across regions including the US and Asia-Pacific or EMEA. Applicants should have a strong...
$122k - $167.75k
...Mondelez España Galletas Production SLU in East Hanover, NJ, seeks a seasoned HR Business Partner to drive its People strategy and optimize workforce performance across multiple teams. With a strong focus on talent acquisition and coaching, this role demands a Bachelor...$133.5k - $192.83k
...Job Title : Digital Consumer Experience Strategy & Research Lead ~ Location: Morristown, NJ About the Job Join the digital engine driving Sanofi’s transformation - where AI, automation, and bold experimentation power faster science and smarter decisions...For contractorsShift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Leader - Strategy & Submissions. Be the first to apply!
- healthcare team leader Madison, NJ
- clinical team leader Madison, NJ
- application team lead Madison, NJ
- team supervisor Madison, NJ
- team coordinator Madison, NJ
- operational excellence leader Madison, NJ
- team leader Madison, NJ
- recruitment team leader Madison, NJ
- group manager Madison, NJ
- school leader Madison, NJ


