Are you a Regulatory Affairs specialist with global experience?
If so, review the job description below and submit your resume for this full-time, permanent opportunity with a highly reputable pharmaceutical company.
The Global Regulatory Affairs Manager is responsible for providing technical regulatory leadership to ensure compliance of commercial products and for the development of Chemistry, Manufacturing and Control (Module 3) strategy for new products under development. Duties and ...
Pharmalink Consulting is recruiting for an Associate Manager, Regulatory Affairs. Mostly under supervision and with limited independence, this position is responsible for review and content of global regulatory CMC issues for products in development, global registrations and approvals, and post-marketing life cycle support. Through ongoing collaboration with Country Operations and Health Authorities (HA), this entry level position’s primary responsibilities are to garner successful approvals, to ...
Pharmalink Consulting is recruiting for a Senior Regulatory Affairs Manager. This position will provide leadership within the Global Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) department by actively contributing to the development and implementation of global CMC regulatory strategies throughout the lifecycle of biologics, pharmaceuticals, and devices. Key day-to-day activities will include the preparation of CMC regulatory submissions that meet global regulatory requirements, ...
Pharmalink Consulting is recruiting for a Regulatory Affairs Manager to work on pharmaceutical advertising and promotions. The major responsibilities and activities include:
Critically review all advertising and promotional materials
Actively Participate in PCR (Promotional Copy Review) process
Serve as the key regulatory contact for PCR
Provide primary regulatory review and oversight for promotion and advertising materials of marketed and to-be-marketed products as well as related sales ...
The Regulatory Affairs Manager will report to Director of Regulatory Affairs and will manage a project and/or team of Regulatory Affairs Professionals.
Preparing and compiling components for regulatory applications, such as: IND, IDE, CTA, NDA, sNDA, ANDA, Annual Reports, BLA, 510k, MAA, variations, and renewals.
Directing others in the preparation of high quality, detailed regulatory documents.
Advising on regulatory strategy and executing specific regulatory projects
This is a Permanent Position.
M.S. or Ph.D. in Pharmaceutics, Life Sciences, Protein Engineering or equivalent
Minimum of 10 years progressive industry experience with biologics development and at least 8 years in Regulatory Affairs
Successful track record with BLA/MAA required – direct responsibility for at least one BLA/MAA is preferred
Practical ‘hands-on” experience in handling US and/or EU registration procedures and other key countries/regions; i.e., prior ...
Global pharmaceutical firm seeking a regulatory affairs manager. This role will see you responsible for managing the firm's regulatory actions and making sure there is compliance with required regulations. If you or someone you know are open to exploring new opportunities please reach out to discuss this position in greater detail. Look forward to speaking with you. Thank you!
- understanding and utilization of product FDA regulations
- strong interpersonal skills
- able to ...
Due to our growing company demands, Pharmalink Consulting, a leader in worldwide regulatory affairs is currently recruiting for all levels of Regulatory Affairs professionals. Opportunities are available at the Associate, Manager, and Senior Manager levels.
Pharmalink provides unrivalled Regulatory Affairs expertise to a diverse client base throughout the world assisting with projects of any scale and length. You will work with some of the world’s leading pharmaceuticals' companies on domestic, ...
The Regulatory Affairs Associate will be responsible for:
- preparing and updating CMC sections of global marketing authorizations
- executing regulatory post-approval filing strategies and variations for global products while ensuring accuracy of all regulatory documents
- tracking project status and effectively communicating progress
- multiple project assignments with critical timelines.
- BA/BS in chemistry, pharmacy, biology or related field.
- Minimum 3-5 years ...
Roles & Responsibilities:
-Performs Drug and Device Registrations for manufacture and other sites as required
-Global Registration dossiers (including generating and providing checks for legalizations, etc.) for US exported products, maintains database
-Trains site specific Quality personnel on Drug Listing requirements
-Responsible for the Voluntary Cosmetic Reporting program
-Acts as Coordinator for NDC numbers
-Performs database searches for Regulatory Information as needed.
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