Director, Regulatory Affairs
EPM Scientific
EPM Scientific in Morristown, New Jersey seeks a Director US Regulatory Lead to provide strategic regulatory leadership across a clinical-stage portfolio. You will lead preparation and lifecycle management of regulatory submissions, including labeling and promotional materials, and act as primary liaison with FDA. You will collaborate with cross-functional teams to support development from early stage through potential approval and commercialization, overseeing INDs, NDAs, and ongoing regulatory #J-18808-Ljbffr
- ...NA $1.00 Responsibilities: Excellent employment opportunity for an Associate Director in the Morris Plains, NJ area. Associate Director in the Regulatory Affairs CMC Department. The successful candidate may lead a small team of RACMC specialists...SuggestedContract workLocal area
$225k - $275k
...a sense of belonging.Join us on our One Perrigo journey as we evolve to win in self-care.Description OverviewAs Senior Director of Regulatory Affairs - Cluster (North America), you are accountable for in-market regulatory activation, execution, and health authority engagement...SuggestedWork at officeLocal areaRemote work2 days per week$182k - $346k
...Initiatives role will develop & advocate strategic positions for CMC regulatory/CMC issues with cross functional internal stakeholders and on... ...experience with at least 8-plus years in regulatory affairs and 5-plus years demonstrated enterprise leadership (as described...SuggestedWork at officeImmediate startRemote workMonday to Friday$140k - $200k
Overview The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory contributor responsible for defining and executing global CMC regulatory strategies for assigned investigational and/or marketed assets. The role partners closely...SuggestedFull timeWork at officeLocal area$215k - $250k
...advancing business goals. Your Role: The Director, US Reguatory Advertising and Promotion... ...promotional materials, ensuring they meet U.S. regulatory standards while supporting clear,... ...Responsibilities: Act as a key regulatory affairs expert within the LMR team, providing...SuggestedPermanent employmentContract workWork at office- ...Responsibilities Define and lead the regional regulatory execution priorities Translate Category regulatory strategies into actionable... ...relationships with health authorities Requirements Degree in Regulatory Affairs, Life Sciences, Pharmacy, or a related field 15+ years of...
- ...information about AbbVie, please visit us at Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global...Worldwide
$225k - $275k
Sr Director of Regulatory Affairs - North America Location: Morristown, NJ, US, 07960 Description Overview As Senior Director of Regulatory Affairs - Cluster (North America), you are accountable for in-market regulatory activation, execution, and health authority engagement...Work at officeLocal areaRemote work2 days per week- ...This individual will be responsible for providing strategic regulatory advice and oversight for all of Altimmune's US regulatory applications... ...FDA. This position reports to the Vice President, Regulatory Affairs. Essential Functions: High-level management of regulatory...Local areaRemote work
- HUTCHMED seeks a Sr Director, Regulatory Affairs to establish and lead regulatory affairs globally. You will craft global registration strategies for US and EU, providing decisive regulatory guidance to product teams and lifecycle planning. The role requires a strong track...
$166.72k - $250.08k
...are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides strategic and tactical regulatory support for U.S. promotional and selected non...Work at office$90k - $200k
...management and enhancement of client relationships. Plan and manage a broad range of complex investigations, forensic accounting, regulatory compliance, including business intelligence, internal (client) investigations, insider risk compliance assessments, consulting...Temporary workFlexible hours$193.04k - $289.56k
...for patients, their families, and society.Job SummaryThe Global Regulatory Lead (GRL) is responsible for leading and developing global... ...interactions. The GRL is responsible for representing Global Regulatory Affairs on the Global Project Team (GPT), as well as in early- and...$70k - $150k
...member of the Financial Investigations teamTake an active role on a broad range of complex investigations, forensic accounting, regulatory compliance, internal (client) investigations, insider risk compliance assessments, consulting projects and forensic matters, with...Temporary workInterim roleFlexible hours$136.5k - $200k
...other marks are property of their respective owners. Position Overview Tonix is looking for a full-time Associate Director, Regulatory Affairs to effectively develop regulatory strategies and submission plans. This position would be responsible for leading...Full timeTemporary workWork at officeLocal areaRemote workFlexible hours- ...Director of Compliance Responsible for all aspects of the organization’s corporate compliance program and associated fraud, waste, and... ...areas (whether such risks are predefined by regulation or regulatory guidance, or identified through organizational experience) for...
- Responsibilities Responsible for all aspects of the organization’s corporate compliance program and associated fraud, waste, and abuse prevention initiatives. Manage the day-to-day activities of the Compliance Division. Develop and update written internal standards of ...
- ...related to product under development. Preparation, submission, and monitoring of PLAIR activities, prior to new product launch Manage regulatory correspondence mainly to CDER, FDA, User fee staff, drug listing and Board of Pharmacies for state licensing submissions. Provide...Local area
$100k - $150k
...commitment to excellence The Company is an equal employment opportunity employer. #LI-AV1 #LI-HYBRID Responsibilities As our Regulatory Compliance Manager , you'll report to the operating unit General Counsel and be responsible for designing, executing and...Full timeWork at officeRemote work$203k - $267k
...Summary This role directs, manages, evaluates and implements regulatory projects in support of company goals in the area of clinical strategy... ...to this job. Other duties may be assigned. Regulatory Affairs Clinical-Nonclinical Strategy Lead the development of regulatory...For contractorsLocal areaFlexible hours- Kroll's North American Investigations, Diligence and Compliance team seeks an Associate Manager based in the United States. The role involves developing and managing investigations, client relationships, proposals, and project management to ensure high‑quality case completion...
- ...Job Description Director of Compliance Responsible for all aspects of the organization's corporate compliance program and... ...risk areas (whether such risks are predefined by regulation or regulatory guidance, or identified through organizational experience) for...Hourly payFull timeTemporary workPart timeFor contractorsFor subcontractorFlexible hoursShift work
- Withum is a place where talent thrives - where who you are matters. It’s a place of endless opportunities for growth. A place where entrepreneurial energy plus inclusive teamwork equals exponential results.Explore different industries. Learn new skills. Connect with our...Full timeContract workWork at officeLocal area
$225k - $275k
Perrigo is seeking a Sr Director of Regulatory Affairs for North America, based in Morristown, NJ. This pivotal role focuses on regulatory activation and engagement with health authorities to drive business growth. The ideal candidate will have extensive regulatory experience...Work at officeRemote work- AbbVie in Florham Park, NJ is seeking a Director Regulatory Affairs Global Regulatory Lead to develop and implement global regulatory strategies across product life cycles. You will lead the GRPT, coordinate with LRST and AST, and drive regulatory excellence in a complex...
$100k - $115k
...in Morris County has led the field for over 40 years. The Sr. Director of Housing Operations, Compliance, and Development oversees compliance... ...President & CEO, this full-time exempt onsite role focuses on regulatory compliance, asset stewardship, and housing development, with a...Full time$127.5k - $184.17k
...’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As an US Regulatory Affairs Senior Manager - Allergy, you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human...Worldwide- Bayer CropScience Limited is seeking a Director of Regulatory Advertising and Promotion to lead strategic regulatory efforts in compliance with U.S. regulations. The ideal candidate will have extensive FDA knowledge, significant experience in promotional submissions, and...
- ...alignment with global frameworks while addressing U.S.-specific regulatory requirements Review and implement (where possible) technology-... ...Provide strategic compliance guidance to Commercial, Medical Affairs, Market Access, Regulatory, and other functional teams Conduct...
- Global Regulatory CMC Manager (Senior Consultant) Duration: 12 Months Max Rate: $50/HR on W2 All inclusive/No Benefits Position Summary We are seeking a highly experienced Global Regulatory CMC Manager (Senior Consultant) to support global Chemistry, Manufacturing & Controls...
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