Regulatory Submissions Lead - FDA & Cross‑Functional
Amneal Pharmaceuticals LLC
Amneal Pharmaceuticals LLC is seeking a Regulatory Affairs Specialist to prepare high‑quality regulatory submissions to the FDA (NDA/IND/BLA) and related documents. The role leads cross‑functional teams across Clinical, CMC, Quality and Marketing to ensure timely delivery and regulatory compliance. The candidate will coordinate with external vendors, organize FDA meetings, and compile briefing packages while maintaining project timeliness. #J-18808-Ljbffr Amneal Pharmaceuticals LLC
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Regulatory Submissions Lead - FDA & Cross‑Functional in Piscataway, NJ vacancy
- ...Palmolive Company is seeking a Regulatory Affairs Project Manager in Piscataway, NJ to lead global regulatory submissions and oversee QMS maintenance... .... You will work across functions to accelerate commercialization... ...ISO 13485, ISO 14971, and FDA compliance within North...Regulatory
- ...Innovative Medicine is seeking a Manager, Regulatory Medical Writing to support across... ...medical writing teams with strategic submission planning and regulatory guidance. Hybrid... ...responsibilities include coordinating cross-functional teams, ensuring quality, and directing...Regulatory
- Amneal Pharmaceuticals is seeking a Regulatory Affairs Specialist to assist with high-quality regulatory submissions to the FDA, ensuring alignment with timelines and guidelines. The role leads regulatory activity on cross-functional teams across Clinical, CMC, Quality,...Regulatory
- About the Role We’re seeking a Fraud & AML Functional Lead to drive the global deployment of next-... .... You’ll work at the intersection of regulatory compliance, fraud prevention, and go-to... ...requirements. Collaborate with cross-functional teams (Product, Engineering,...RegulatoryFull timeWorldwide
- Breckenridge Pharmaceutical, Inc. is seeking a Regulatory Operations professional to oversee FDA eCTD submissions, NDAs, INDs, ANDAs and related documents,... ...track regulatory records, and collaborate with cross-functional teams to align on FDA/ICH requirements and SOPs...RegulatoryFlexible hours
- ...Remote50% RemoteSummary: Our client is a leading medical device company and is seeking... ...remediation initiative supporting medical device regulatory compliance. This consultant will assess... ...remediation plans, and partner with cross-functional teams to implement sustainable process...Regulatory
- .... in New Jersey seeks an Associate Director of Regulatory Affairs Advertising and Promotion to provide strategic... ...portfolio. You will review materials for FDA compliance, provide risk-based guidance, and lead cross-functional review discussions to ensure timely, compliant...Regulatory
$100k - $110k
...countries and regions.Job Title: Procurement Lead, Direct MaterialsLocation: Piscataway,... ...analysis. Close collaboration with cross-functional teams is essential to ensure supply continuity, compliance with quality and regulatory standards, and readiness for audit requirements...RegulatoryLong term contractTemporary workRemote workFlexible hours$109.6k - $155k
...our Procurement Innovation & Integration Lead you will be the strategic architect of... ...business narratives that drive cross functional alignmentChampion the digital change management... ...Health and Safety, Quality, and Regulatory compliance standardsOversee critical supplier...RegulatoryHourly payLocal areaRelocation package- GenScript USA Inc. is seeking a Procurement Lead for Direct Materials in Piscataway, NJ.... ...cost-saving initiatives while ensuring regulatory compliance and audit readiness. The... ...contracts, and collaborate with cross-functional teams to maintain supply continuity in...Regulatory
$130k - $200k
A leading biotechnology company is seeking a Director of Regulatory Affairs for Infectious Diseases. This position is responsible for overseeing global regulatory strategies, submissions, and cross-functional leadership. The ideal candidate will possess a strong scientific...RegulatoryRemote job$117k - $120k
AMNEAL PHARMACEUTICALS Regulatory Affairs Specialist: With minimal supervision... ...of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company... ...serves as regulatory lead on cross functional teams including Clinical, CMC,...RegulatoryFor contractorsLocal area$94k - $151.8k
...recognize their merit.Job Function: Sales EnablementJob... ...is recruiting for a Lead Analyst, Contract Management... ...on handling RFP/RFI submissions, contract authoring,... ...and indirectly manage cross functional teams.... ..., as may be required, regulatory approvals and other customary...RegulatoryFull timeContract workWork at officeLocal areaImmediate start- GenScript USA Inc. in New Jersey seeks a Procurement Lead for Direct Materials to lead the direct procurement... ..., drive cost-saving initiatives, ensure regulatory compliance, and collaborate cross-functionally to maintain supply continuity in a fast-paced environment...Regulatory
- A leading staffing solutions provider in New Jersey is seeking a Regulatory Affairs Associate to prepare and submit annual reports to the FDA. The ideal candidate will have a Master’s degree in Science... ...include coordinating submissions and maintaining regulatory databases...Regulatory
- Creative Solutions Services, LLC seeks a seasoned Regulatory Publishing Professional to lead IND/NDA/ANDA submissions and related regulatory packages for the US market. The role requires hands-on experience with eCTD/NeeS publishing, archival processes, and tools like DocuBridge...Regulatory
- ...a Global Viral Vector MSAT Lead as part of the Global Manufacturing... ..., Manufacturing, Quality, Regulatory, and Supply Chain teams to... ...trending. Partner cross‑functionally to identify and mitigate manufacturing... ...input to CMC regulatory submissions, health authority...RegulatoryPermanent employmentFull timeFor contractorsLocal areaWorldwide
- Katalyst CRO in Edison, NJ is seeking a qualified individual to lead publishing activities for regulatory submissions. The ideal candidate has a Bachelor’s or Master’s degree in Pharmacy or Life Sciences, with 5-10 years of experience in eCTD/NeeS publishing. Responsibilities...Regulatory
$256.07k - $336.1k
...the single point of accountability for leading cross-functional teams to define and execute... ...across Research, Clinical Development, Regulatory Affairs, Translational Sciences, Technical... ...and alignment for INDs, CTAs, BLA/MAA submissions, and lifecycle management activities....RegulatoryPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hoursLegend Biotech USA, Inc.
Somerset, NJ11 days ago- ...SUBMIT YOUR RESUME Job TitleLead SAP GTS Functional Consultant ExperienceMinimum 10+ Years... ....com We are seeking a distinguished Lead SAP GTS Consultant to serve as the Global... ...Sciences experience , understanding the unique regulatory and compliance requirements within the...RegulatoryFull time
$175k - $300k
...and recognize their merit.Job Function: Medical Affairs GroupJob Sub... ...treatments and cures. We lead where medicine is going and need... ..., which is the key strategic cross-functional team in charge of... ...data reviews and analysis, and regulatory environment.Knowledge of...RegulatoryFull timeLocal areaImmediate startWorldwide- ...across the pharma R&D value chain, including Regulatory, Safety, Medical Affairs, and Clinical... ...strategies and technical roadmaps, and lead assessments to identify opportunities in... ...knowledge and experience as a techno-functional manager guiding projects, proposals, #J...Regulatory
- ...Payment Modernization Initiative Lead This role requires someone who has migrated... ...integrations Collaborate with cross functional teams to define requirements, map processes... ..., and design solutions that align with regulatory, compliance and operational standards....Regulatory
Omni Inclusive
Iselin, NJ9 hours ago - ...Environmental Health and Safety Manager to lead EHS programs across two sites in New... .... The role requires ensuring regulatory adherence (OSHA, FDA/cGMP) while fostering a strong safety... ..., training, audits, and cross-functional collaboration #J-18808-Ljbffr Kashiv...Regulatory
$164k - $282.9k
...and recognize their merit.Job Function: Medical Affairs GroupJob Sub... ...treatments and cures. We lead where medicine is going and need... ...ensuring compliance with J&J Cross-Pharma Policies and SOPs (e.g... ...stakeholders (Medical Affairs, R&D, regulatory, outcomes research,...RegulatoryFull timeLocal area$94k - $151.8k
...and recognize their merit.Job Function: Sales EnablementJob Sub... ...Johnson is recruiting for a Lead Analyst, Contract Management... ...execution quality and speed.Cross-Functional PartnershipCoordinate... ...Administration, Problem Solving, Regulatory Compliance, Relationship Building...RegulatoryFull timeContract workTemporary workWork at officeLocal area- ...Description: SUMMARY: The Encapsulation Lead Operator is responsible for overseeing... ...all activities comply with cGMP, SOPs, and regulatory requirements. •\tPerform basic... ...identify areas for improvement. •\tProvide cross-training and operational support across manufacturing...Regulatory
ASPIRE PHARMACEUTICALS INC
Somerset, NJmore than 2 months ago - ...preclinical to life cycle management. You will lead a global team, ensure timely, high-quality... ...statistical innovations, define KPIs, and partner with cross-functional leaders to shape development strategies and regulatory submissions in oncology programs. #J-18808-Ljbffr...Regulatory
$119k - $224k
...Technology AI Transformation team is seeking a Lead Business Execution Consultant to... ...In this role, you will: Lead cross functional teams to strategize, plan, and execute... ...Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively...RegulatoryFull timeWork experience placementRelocation packageWells Fargo
Iselin, NJ1 day ago- Johnson & Johnson Innovative Medicine in the United States seeks a Senior Manager for Regulatory Policy Research to lead complex cross‑functional work within GRPI and GRA, shaping policy strategy and enabling proactive regulatory engagement. You will develop high‑quality...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Submissions Lead - FDA & Cross‑Functional. Be the first to apply!
