Director, Regulatory Affairs
Organon
Organon is seeking a Director of Nonclinical Development to provide expert nonclinical support across Women's Health, General Medicines, and Biosimilars. The role teams with Regulatory, Safety, and CMC, contributing to global regulatory submissions and product lifecycle management. You will author nonclinical sections, participate in agency interactions, and guide risk assessments related to CMC activities, while leading cross-functional groups to ensure GLP/GCP compliance and regulatory success. #J-18808-Ljbffr
$128.8k - $358.8k
...Job Title Direct, oversee and manage large, complex, regulatory projects, ensuring quality deliverables on time and within budget.... ...compliance of regulatory processes and prepares for full Regulatory Affairs Systems Audits, accountable for any subsequent action plans...SuggestedFull timePart timeWork at officeImmediate startWorldwideFlexible hours$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...SuggestedFor contractorsLocal areaFlexible hours- ...information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global...SuggestedWorldwide
- ...AbbVie is seeking a Senior Manager to lead US & Canada regulatory strategy for Neurotoxins, developing and executing regulatory plans and guiding filings with health authorities. The role requires an advanced degree and 5+ years in regulatory/R&D, strong negotiation and...Suggested
$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$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...Full timeWork at officeLocal area$225k - $275k
...Description Overview As Senior Director of Regulatory Affairs – Cluster (North America), you are accountable for in-market regulatory activation, execution, and health authority engagement across the cluster, translating Category Regulatory strategy into effective local...Local area- ...: 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
- ...and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job Description• Assist and support regulatory CMC managers in the following activities:• Defining global CMC regulatory strategy and decisions for development projects or marketed...Immediate start
$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$108.5k - $201.5k
...and financial processes evolve, and bring clarity to complex regulatory and audit landscapes. This role offers the opportunity to grow... ...collaboratively across functions and levels, including Associate Director and Director stakeholdersProven capability to manage multiple...Full time$106.79k - $189.5k
Regulatory Affairs Compliance ManagerPBF Energy Inc. (NYSE:PBF) is one of the largest independent refiners in North America, operating through its subsidiaries, oil refineries and related facilities. We are seeking a talented Regulatory Affairs Compliance Manager to join...Full timeWork experience placement$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 team Take 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- ...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...Contract workLocal 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$150k - $200k
...Human by nature.Join us as our next Head of Systems Strategy - Regulatory, reporting to our Global Head of Regulatory Compliance &... ...transformation strategy.You will be a bridge between Regulatory Affairs, Product Safety, IT, and Business and other departmental teams...$249.1k - $327k
...work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.The Senior Director, Global Regulatory Affairs, Neurology will identify and implement company regulatory strategies for the global Neurology or Oncology portfolio as...Full timeTemporary workRemote work3 days per week- ...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
$103k - $129k
...drivers to leadership. This position will report to the Associate Director, Government Pricing & Compliance.How You’ll Spend Your... ...attributes across internal and external platforms to support regulatory review and reporting for both new product launches and existing...Contract workTemporary workLocal areaWorldwideFlexible hours- ...provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job DescriptionResponsible for implementing regulatory strategy and managing operational activities for assigned regions.Provides input into global regulatory strategy, including...Work at officeImmediate startWorldwide
- ...Job Description Role Overview The Associate Manager, Regulatory Affairs supports the planning, preparation, submission, and maintenance... ...Primary Duties & Responsibilities Support the Associate Director of Regulatory Affairs in executing regulatory strategies for...Full timeWork at officeLocal areaMonday to FridayNight shift
$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- Daiichi Sankyo, Inc. seeks an Associate Director, Regulatory Affairs Advertising and Promotion to provide regulatory review and strategic guidance for U.S. promotional and some non-promotional communications across its portfolio. Reporting to the Head of RAAP, this role...
- 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...
- 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
$86.7k - $170.9k
Position Summary Consultant - Regulatory & Compliance - Enterprise Operations & Risk Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen, protect...Local areaVisa sponsorship- Scorpion Therapeutics is seeking a Senior Director of Regulatory Affairs - Cluster (North America) to drive in-market regulatory activation and execution across the cluster. You will translate strategy into local execution, manage health authority engagement, and lead...Local area
$204k - $231k
WTW is expanding its Technology Risk & Assurance (TRA) capability to strengthen technology governance, risk management, and regulatory readiness across the enterprise. TRA serves as an embedded risk and control function within Global Technology, partnering closely with...Temporary workLocal areaRemote workFlexible hours- 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...
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