Pharmaceutical Clinical Associates, LLC
-
Hoboken,
NJ
Provide strategic regulatory support to quality operations (QC/QA/Compliance), manufacturing, packaging, and component and product release sites - for Forest Laboratories, partners, and external Contract Manufacturing Organizations.
Design, develop, and manage a Change Control system for Regulatory CMC department. Serve as primary point of contact across all groups to evaluate the CMC related changes and determine the appropriate filing category for all products. Track and monitor all submissions associated with specific change controls at all sites.
Promptly communicate regulatory approvals to all impacted functional groups (quality, manufacturing, packaging, release sites, R&D, etc.) and/or other appropriate information in support of registrations.
Represent Regulatory CMC in Health Authority Inspections and/or internal audits to support of quality and manufacturing groups.
Provide support to quality, manufacturing, and R&D groups in supplier/vendor selection processes and qualifications.
Procures all supportive internal documentation (data, reports, etc.) as well as external information (letters of authorization for DMFs, BSE/TSE certifications, etc.) in support of all regulatory submissions (pre-approval and post-approval).
Interact and liaise with other internal regulatory CMC colleagues and keep them informed on all site/scale/manufacturing site changes in support of their projects and corporate objectives.
Provide oral presentations and written reports as necessary to management on matters relating to CMC activities.
Coordinate pre-submission meetings with regulatory agencies as needed.
Experience and Skills:
Education:
BS/MS/PhD in Pharmacy, Chemistry, Chemical Engineering or a related discipline.
Experience:
Minimum 8+ years of relevant experience in a regulated environment.
Direct experience (pre- or post-approval) interacting with the FDA is a plus.
Hands on experience in pharmaceutical product development and/or manufacturing is preferred.
Licensure/Credentials:
Regulatory Affairs Certification (RAC) or a Certified Quality Engineer (CQE) Certification is desirable.
Knowledge, Skills, and Abilities
Strong working knowledge of manufacturing unit operations (including packaging) and Scale-Up and Post Approval Changes (SUPAC)
Excellent verbal and written communication skills
Ability to work under pressure and manage multiple projects simultaneously
Detail/accuracy oriented
Collaborative and willing to learn
Additional Information:
Job Level: Management
Number of Openings: 1
Years of Experience: At least 7 Years
Level of Education: BA/BS
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Hoboken, NJ
Hoboken, New Jersey
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