CMC Regulatory Strategy Lead
Shionogi Inc.
Shionogi Inc. is seeking a Senior Manager, Regulatory Affairs CMC to provide strategic leadership for CMC regulatory activities and ensure alignment with pipeline objectives. You will collaborate with cross-functional teams and regulatory authorities to drive compliant submissions and timely product development. Based at our Florham Park, NJ site, this hybrid role requires 5+ years in regulatory affairs focused on CMC, strong communication, and the ability to manage INDs, NDAs, and MAAs through #J-18808-Ljbffr
- ...seeking a Senior Manager/Associate Director, Regulatory Affairs CMC to define and execute global CMC regulatory strategies for investigational and/or marketed assets. The... ...content with a risk-based approach. You will lead cross‑functional teams, manage timelines, and...Regulatory
- ...AbbVie is seeking a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada. You will develop and implement strategic and tactical plans for US and Canada regulatory compliance, ensuring alignment with the GRPT and business needs. You will interface with...Regulatory
- ...Shionogi Inc. in Florham Park, NJ is seeking a Senior Manager, Regulatory Affairs CMC to lead strategic CMC regulatory activities under the guidance of the Senior Director. You will coordinate with R&D, QA, manufacturing, and commercial teams to align regulatory plans...Regulatory
- ...Breckenridge Pharmaceutical is seeking a Regulatory Affairs Manager to support regulatory CMC strategies and submissions for generic products, including complex sterile... ...to the Director of Regulatory Affairs, you will lead regulatory activities for assigned programs,...Regulatory
- AbbVie in Florham Park, NJ seeks a Senior Manager Regulatory Affairs to lead US & Canada regulatory strategy. You will develop and implement plans, coordinate FDA interactions, and guide submissions across therapeutic areas. Hybrid schedule with in-office and remote days...RegulatoryWork at officeRemote work
- ...LEO Pharma is seeking an Associate Medical Director to lead the U.S. medical strategy for Tralokinumab in Atopic Dermatitis. The role will work... ...based out of the Madison, NJ office and requires strong regulatory and medical expertise, with potential for mentoring within...RegulatoryWork at office
- ...Sanofi is seeking a Medical Director, Pulmonary, to lead the US medical/scientific strategy for Pulmonary products within Immunology Medical Affairs. You will partner with Clinical, Commercial, Regulatory and Market Access to drive evidence generation and medical engagement...Regulatory
- Sanofi seeks a Biostatistics Franchise Lead in the US to guide a vaccines development portfolio. You will lead biostatistics strategy, oversee a multidisciplinary team, and ensure... ...stages. You will partner with clinical, regulatory, and medical teams to translate data into...Regulatory
- ...US is seeking a US Medical Director for Transplantation to lead the medical strategy for belumosudil and related transplant programs in the... ...Sponsored and Company Sponsored studies, coordinate with regulatory and reimbursement teams, and ensure compliant medical practices...Regulatory
- ...Executive Director for the GxP Center of Excellence to lead enterprise-wide quality strategies across GCP, GLP, and GVP domains. You will drive... ...role requires deep experience in GxP quality leadership, regulatory knowledge, and the ability to collaborate with R&D, regulatory...Regulatory
$185.5k - $344.5k
...customer engagement, and drive innovation. The Strategy, Platforms & Transformations team is... .... Strategic Discovery & Innovation: Lead discovery initiatives, design‑thinking workshops... ...the pharmaceutical industry, including regulatory requirements, market dynamics, and the...RegulatoryWorldwide$150k - $180k
Emerson in Florham Park, NJ, is looking for a Global Trade Compliance Director to lead regulatory and compliance strategies across their Fluid and Motion Control businesses. This role requires strong leadership in managing trade compliance and developing effective international...Regulatory- ...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 products to achieve optimal...RegulatoryImmediate start
- ...Sanofi seeks a Senior Director of Franchise Digital Strategy & AI Innovation in Morristown, NJ to lead precision marketing and content strategy across HCP... ..., and collaborate with Commercial, Medical Affairs, Regulatory, and IT to align digital and content strategies with...Regulatory
$130.7k - $196.1k
...strategic, and forward‑looking Operational Technology (OT) Strategy Leader to lead the digital transformation and enhance operational... ...governance.Monitor industry trends, emerging technologies, and regulatory requirements to ensure the OT strategy remains current, compliant...RegulatoryTemporary workWork experience placementFlexible hours- ...is seeking an Associate Director, MSL to lead and develop the field medical science... ...team, aligning activities with the medical strategy and regional goals.You will coach field... ...stakeholder relationships while ensuring regulatory compliance and travel up to 50-60% as...Regulatory
- ...Job title : Launch Acceleration and Regulatory Enablement Lead ~ Location: Morristown, NJ/Cambridge... ...matter expert on regulatory submission strategies, an energetic communicator equally... ...scientific and regulatory messaging across CMC, Clinical, Nonclinical, and Safety...RegulatoryShift work
- ...Job Title: Global Regulatory CMC Manager Duration: This is a 6-month assignment. Summary... ...develop global regulatory CMC strategies and partner with key stakeholders to execute... ...background packages (including participating / leading HA meetings with support); and/or post-...Regulatory
- ...Morristown, NJ or in other listed U.S. offices, you will lead lifecycle strategy, P&L, and market positioning across the CHI capsule portfolio... ...initiatives and pricing strategies. Strong leadership and regulatory insight are required. #J-18808-Ljbffr Lonza Group Ltd.Regulatory
- Opella seeks a Global HCP Lead to advance our multi-channel HCP marketing strategy across a global footprint. You will define the global HCP framework, develop... ..., and ensure alignment with brand and regulatory requirements. You will mentor teams, translate scientific...Regulatory
- ...seeking a US Medical Director for Transplantation Kidney to lead the medical strategy for kidney transplantation and related therapies. You will oversee medical affairs activities, collaborate with regulatory and commercial teams, and drive evidence generation to support...Regulatory
- Shionogi Inc. in Florham Park, NJ, seeks a Senior Manager, Regulatory Affairs CMC to lead strategy and coordination of CMC regulatory activities under the Senior Director, CMC. You will partner with R&D, QA, manufacturing, and regulatory authorities to ensure compliant...Regulatory
$140k - $170k
...Overview The Senior Manager, Regulatory Affairs CMC supports the CMC team under the guidance of the Senior Director, CMC. In this role,... ...cross‑functional teams to develop and implement regulatory strategies for CMC aspects of product development. This involves assessing...RegulatoryFull timeLocal areaWork from home2 days per week3 days per week- ...US is seeking an experienced professional to lead the development and implementation of companion diagnostics (CDx) strategy within the Early and Late-Stage Development... ...therapeutics, spanning assay development to regulatory submissions. The position requires deep expertise...Regulatory
- ...Description Job Title: Manager, Congress Strategy & Orchestration (CS&O) \n Location:... ...partners, Medical Affairs, Legal, Regulatory and Compliance. The Manager helps integrate... ...marketing skills \n Influencing and leading without direct authority \n Stakeholder...Regulatory
$140k - $200k
The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory... ...and executing global CMC regulatory strategies for assigned investigational and/or marketed... ...health authorities. Responsibilities Lead development of Global CMC regulatory...RegulatoryFull timeWork at officeLocal area- ...AbbVie is seeking a Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology to lead regulatory strategies for immunology products. You will oversight activities, mentor staff, and influence the regulatory environment across multiple therapeutic areas...Regulatory
- ...Daiichi Sankyo is seeking a Director, Global Labeling Strategist to lead global regulatory labeling strategies for a major product and potential future products under a global alliance. The role guides labeling content development, maintains CCDS and country labeling,...Regulatory
$185.5k - $344.5k
...international) will be defined by the hiring manager. This position will require up to 20% travel.Reporting into the ED, US Business Strategy Lead, this role leads day-to-day strategy engagements within US Business Strategy, translating the pillar lead’s agenda into...Full timeLocal areaRemote workRelocation- ...is seeking a Senior Director to lead drug substance development and manufacturing strategy for peptide APIs, interfacing with... ...CDMOs and internal Quality, Regulatory, and program teams. The role... ...development, scale-up, and regulatory CMC leadership. Hybrid work...Regulatory
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