- Merck & Co. (Rahway, NJ)
- Job Description Associate Director , Regulatory Submissions Archive Operations - Location: Rahway, NJ (Hybrid role - onsite 3 days per week required) - Functional ... Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director of Regulatory Submissions Archive Operations serves as the Business System Owner (BSO)… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... the regional regulatory strategy, objectives, policies, and programs pertaining to developing...marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC post ... approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders...assessments, and coordinating with regional RA-CMC leaders to formulate regulatory strategies for post-approval changes. This role will also… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Director , Global Regulatory , Growth Markets will be responsible for providing regulatory ... growth markets such as Latin America, the Middle East, and Africa.The Director will manage regulatory submissions, registrations, and lifecycle management… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global ... regulatory strategies and plans to enable efficient, competitive product...product development for assigned programs. This role will provide regulatory input to global cross-functional project teams throughout product… more
- Insmed Incorporated (NJ)
- …what's possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing, ... in. Are you?About the Role:We're looking for an Associate, Regulatory Operations on the Regulatory team to...management, and submission of regulatory documents in accordance with global health authority requirements.… more
- Eisai, Inc (Nutley, NJ)
- …that optimize cost, enhance vendor performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, governance ... this is your profile, we want to hear from you. The Senior Director of Clinical Outsourcing provides strategic leadership for global outsourcing and vendor… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …Brief Description of Duties: Under the supervision of the City Administrator, the Director of Community Development is an exempt position under FLSA. Ensuring that ... independent judgement and simultaneously considering the financial, ethical, legal and regulatory variables that affect the City is vital. Performs complex and… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Director , Global Labeling is responsible for the leadership and oversight of the Labeling function ... within Global Regulatory Services and Operations (GRSO). This position will manage...Salary Transparency Language:The annual base salary range for the Director , Global Labeling is from :$180,700-$237,200Under current guidelines, this… more
- Merck & Co. (Rahway, NJ)
- …business objectives of the brand while ensuring adherence to internal processes and regulatory guidelines.- To prepare for these launches, we are looking for an ... Associate Director (AD) to join our center of excellence.Description:-Under the...point of contact on each.- Interacting with internal marketing, regulatory , and trademark legal colleagues and third- party vendors,… more
- Merck & Co. (Rahway, NJ)
- …highly experienced and motivated individual to join our team as the Director of Biologics- Materials and Biophysical Characterization. The successful candidate will ... with cross-functional teams, including research, development, quality control, and regulatory affairs, to ensure comprehensive biophysical characterization of products.Ensure… more
- Merck & Co. (Rahway, NJ)
- …and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a ... frictionless flow of data from source systems to regulatory documentation.- - - Under the guidance of dCMC... documentation.- - - Under the guidance of dCMC Regulatory -Authoring Leadership, the Associate Principal Scientist, Regulatory … more
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Director of Clinical Outsourcing is responsible for leading the development and execution of ... deliver cost efficiencies, enhance vendor performance, and ensure compliance with regulatory and corporate standards. This role manages CRO and vendor relationships,… more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand what's possible for ... Reporting to the VP, Clinical Development - Gene Therapy, the Executive Director will have responsibility to lead clinical programs across different diseases and… more
- Eisai, Inc (Dallas, TX)
- …If this is your profile, we want to hear from you. The Associate Director , Access and Reimbursement (AD ARM) will lead the Eisai Access and Reimbursement Managers ... areas related to field reimbursement services.Working closely with and reporting to the Director , Access and Reimbursement, the AD ARM will be responsible for the… more
- Insmed Incorporated (San Diego, CA)
- …the future of science, we're in. Are you?About the Role:We're looking for a Director , Clinical Scientist for the Gene Therapy Clinical Development team to help us ... what's possible for patients with serious diseases. Reporting to the Executive Director , Clinical Development, you will support and work predominately with the… more
- Merck & Co. (Lenexa, KS)
- …livestock (beef, dairy, swine, poultry, aquaculture). Reporting to the Executive Director , Channel Operations & Engagement, you will connect brand teams, ... marketing teams within the organization along with sales, product development, regulatory affairs, customer service, and other cross-functional teams to ensure an… more
- Merck & Co. (North Wales, PA)
- …Program Marketing across the Immunology portfolio.- This position will report to the Director , US Marketing Patient Support.- The Associate Director will shape ... stakeholder to define go-to-market plans for the PSP. - The Associate Director , US Marketing, Patient Support Strategy & Effectiveness is responsible for shaping… more
- Formation Bio (New York, NY)
- …more efficiently.About the PositionFormation Bio is seeking a motivated, experienced Director , Formulation Development to join our dynamic team. This critical role ... of technical expertise, strategic thinking, leadership capabilities, and a strong regulatory and industry knowledge base in pharmaceutical sciences or engineering to… more
- Formation Bio (New York, NY)
- …faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director , Program Management - Asset Diligence & Integration to partner with our ... initial evaluation to pre-close. Coordinate cross-functional workstreams (Clinical, CMC, Regulatory , Nonclinical, QA, Commercial, Finance, Legal/IP). Maintain trackers, RAID… more
