Current jobs related to Senior CMC Regulatory Affairs - Rahway - Cynet Systems
-
Lead CMC Regulatory Affairs Specialist
1 week ago
Rahway, New Jersey, United States Insight Global Full time**Become a Key Player as a Lead CMC Regulatory Affairs Specialist** Insight Global is in search of a committed professional to join the Global Regulatory Affairs division of a leading pharmaceutical organization. **Key Responsibilities Include:** Crafting comprehensive CMC regulatory approaches Preparing a variety of regulatory CMC documents including...
-
Regulatory Affairs Director
12 hours ago
Rahway, New Jersey, United States MSD Malaysia Full timeJob DescriptionJob SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at MSD Malaysia. As a key member of our Regulatory Affairs Department, you will be responsible for managing a team of Regulatory Affairs Specialists and ensuring the smooth operation of all registration activities across the teams defined...
-
Lead Regulatory Affairs Specialist
1 week ago
Rahway, New Jersey, United States Katalyst Healthcares and Life Sciences Full timeKey Responsibilities and Qualifications: Independently assist core teams in the development of new products by formulating regulatory strategies and preparing necessary documentation for both domestic and international submissions related to IVD medical devices, emphasizing instrumentation and software/hardware, along with experience in assay development....
-
Lead Regulatory Affairs Specialist
1 week ago
Rahway, New Jersey, United States Katalyst Healthcares and Life Sciences Full timeKey Responsibilities and Qualifications: Independently contribute to new product development teams by formulating regulatory strategies and preparing necessary documentation for both domestic and international submissions concerning IVD medical devices, emphasizing instrumentation and software/hardware, alongside experience in assay development. Proven...
-
Senior Regulatory Specialist
2 weeks ago
Rahway, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities and Requirements: utonomously support new product development core teams including development of regulatory strategies and the preparation of regulatory content for domestic and international submissions for IVD medical devices to support the core team's approved scope of regulatory activities, with focus on instrumentation and...
-
Director of Regulatory Compliance
12 hours ago
Rahway, New Jersey, United States MSD Malaysia Full timeJob DescriptionJob SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at MSD Malaysia. The successful candidate will be responsible for managing a team of Regulatory Affairs Specialists and ensuring the smooth operation of all registration activities across the teams defined responsibilities.Key...
-
Senior Documentation Specialist
2 months ago
Rahway, United States Pyramid Consulting, Inc Full timeImmediate need for a talented Senior Documentation Specialist - III. This is a 15+ months contract opportunity with long-term potential and is located in Rahway, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID: 24-34389Pay Range: $40 - $45/hour. Employee benefits include, but are not limited to, health...
-
Senior Documentation Specialist
4 weeks ago
Rahway, United States Pyramid Consulting, Inc Full timeImmediate need for a talented Senior Documentation Specialist - III. This is a 15+ months contract opportunity with long-term potential and is located in Rahway, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID: 24-34389Pay Range: $40 - $45/hour. Employee benefits include, but are not limited to, health...
-
Executive Director, Structure Characterization
2 months ago
Rahway, United States Merck & Co. Full timeThe Executive Director of Structure Characterization & Elucidation is responsible for providing strategic and technical leadership to enable deep structural understanding of drug substances and drug products and successful advancement of small molecules, biologics, and vaccines from discovery through development and commercial launch and into supply for...
-
Senior Principal Scientist
1 week ago
Rahway, New Jersey, United States Merck Sharp & Dohme Full timePosition Overview:The Large Molecule Analytical Validation team within the Analytical Research & Development sector at Merck Sharp & Dohme is on the lookout for a dedicated Senior Principal Scientist. This role requires profound technical acumen in formulating strategies for critical reagents associated with large molecules. Role Responsibilities:The Senior...
-
Senior Statistical Programming Scientist
1 week ago
Rahway, New Jersey, United States Merck & Company, Inc. Full timePosition OverviewThe Senior Statistical Programming Scientist plays a pivotal role in the realm of Clinical Trial Analysis and Reporting. This position is responsible for overseeing the statistical programming efforts associated with multiple and/or large-scale complex late-stage drug and vaccine clinical development projects.Key ResponsibilitiesLead...
-
Rahway, New Jersey, United States MSD Malaysia Full timeSenior Principal Scientist/Senior Director, Precision BioinformaticsMSD Malaysia is seeking a highly experienced computational biologist to lead our Companion Diagnostics (CDx) efforts in San Diego.Job Summary:We are looking for a senior leader to oversee the development of a flexible AI/ML engine for precision bioinformatics, leveraging human data to...
-
Senior Operations Specialist
4 weeks ago
Rahway, United States MSD Malaysia Full timeSenior Operations Specialist - Facilities and Project Lead Job Description The West Point, PA campus is our Company’s largest vaccine manufacturing facility with more than 2000 employees. This facility manufactures bulk and/or final dosage forms for all our Company vaccine products and is growing to meet the vaccine demands of the future. The Building 50...
-
Senior Director of Health, Safety, and Environment
24 minutes ago
Rahway, New Jersey, United States ESR Healthcare Full timeJob SummaryWe are seeking an experienced Health, Safety, and Environment Director to join our team at ESR Healthcare. As a key member of our organization, you will play a critical role in driving our safety culture, developing our HSE strategy, and ensuring compliance with regulatory requirements.Key Responsibilities:Lead and manage the development and...
-
Rahway, United States MSD Malaysia Full timeSenior Principal Scientist/Senior Director, Precision Bioinformatics Job DescriptionThe Precision Genetics group within the Data and Genome Sciences Department is recruiting a Sr. Principal Scientist, Precision Bioinformatics site lead for our San Diego based Companion Diagnostics (CDx) efforts. We are seeking an experienced computational biologist with a...
-
Oncology Portfolio Project Manager
4 weeks ago
Rahway, United States NavitsPartners Full timeJob DescriptionJob DescriptionJob Title: Oncology Portfolio Project ManagerLocation: Rahway, NJ 07065Duration: 12 MonthsJob Description:Ensure robust engagement among global, regional, and local markets on Oncology New Product.Monitor and update GRL approach: Track and provide visibility (next 1-2 years) of evolving Pan, Early, Launch global commercial team...
-
Quality Control Analytical Chemist
1 week ago
Rahway, New Jersey, United States Astrix Inc Full timeAstrix Inc. is a prominent player in the pharmaceutical sector, focused on pioneering drug solutions that enhance patient care. Our commitment to scientific integrity and stringent quality protocols is evident in every facet of our operations. Position Overview: We are in search of a dedicated Analytical Chemist to become an integral part of our team. The...
-
Scientific Project Coordinator
1 week ago
Rahway, New Jersey, United States Careerbuilder-US Full timeJob Title: Scientific Project Coordinator Job Location: Rahway, NJ and Upper Gwynedd, PA Job Duration: 12 months+ Pay Range: $55 - $61.87/hr on W2 Shift: Hybrid role - 3 days onsite required each week. Job Overview: We are in search of a proactive and innovative Scientific Project Coordinator who will play a pivotal role in steering our Strategic...
-
Rahway, New Jersey, United States DPS Group Global Full timePosition OverviewDPS Group is seeking a qualified BioPharma Senior Process Project Engineer to oversee equipment commissioning, calibration activities, and documentation within a GMP environment. The successful candidate will possess the necessary skills and technical expertise to support project timelines, documentation, facilities, and vendor resources,...
-
Analytical Chemist
2 months ago
Rahway, United States Astrix Full timeOur client is a leading pharmaceutical company dedicated to developing innovative drug products that improve patient outcomes. They are committed to scientific excellence and rigorous quality standards in all aspects of our operations.Location: Rahway, NJSchedule: Mon-Fri 8:30 a.m. - 5 p.m.Pay: $27.39/hrJob Type: 1-year Contract Position Overview: We are...
Senior CMC Regulatory Affairs
3 months ago
Pay Range $38hr - $43hr
Responsibilities:
- Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference Member States.
- Manage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration renewals, response to health authority questions, assessment reports and Expert reports.
- Experience in reviewing CMC quality documents like Product development report, process validation, method validation, stability data, finished product specification as per guideline.
- Knowledge on relevant regulatory guidelines VICH guideline, USP, EU, ICH guidelines and relevant applications.
- Requirements for veterinary products and guidance (not limited to QRD veterinary template, guideline on SPCs for antimicrobials, MRL etc).
- Lead development and execution of global product and project regulatory, strategy(ies) for assigned Veterinary products in accordance with global regulations and guidance.
- Review of artworks / labelling, SmPC and pack insert.
- Comparison of CPCs (Critical Pharmaceutical Characteristics), Prepare and submit a proposal of a harmonised SPC.
- Evaluation and Assessment of change control and develop a plan with a timeline to implement the same.
- Knowledge and experience on reviewing the DMF and assessment of Drug substance related changes, gap analysis and authoring of corresponding variation packages.
- Hands on experience on authoring CMC documentation for worldwide marketing of Veterinary products for initial registration and life-cycle management.
- Planning the project by understanding the client needs, managing project deliverables and providing solutions in real time.
- Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders.
- Deliver all regulatory milestones as per agreed SLAs with clients.
- Identify, communicate and escalate potential regulatory issues / risks and propose mitigation.
- Experience should be 4 to 7 years.
- Bachelor's or master's degree required in science, engineering or related field (advanced degree preferred).
- Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields.
- Knowledge and hands on experience on Animal Health CMC.
- Marketing authorization experience.
- Proven Project Management experience.