Regulatory Affairs CMC Compliance Manager
Job Type:
Regular Full-Time
Location:
Morris Plains, NJ
Job Description:
Dendreon is seeking a Regulatory Affairs CMC Compliance Manager to represent regulatory on cross functional teams to provide advice on the regulatory impact of process or facility changes or material review board assessments. The successful candidate will have excellent oral and written communication skills, and problem solving analytical skills.
General Summary:
Provides Regulatory leadership at the for Chemistry, Manufacturing, and Controls and Facility related areas, which may include one or more of the following:
Assesses the regulatory impact of process or facility changes.
Participates in the implementation of critical path strategies.
Reviews and approves SOPS, validation reports, and technical reports for regulatory compliance.
Assesses the impact of additions/changes to regulations and guidelines, and evaluates relevance to company and product interests.
Provides technical expertise to other departments as part of cross-functional project teams.
Develops and implements processes to ensure regulatory compliance.
Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.
Reviews regulatory compliance validation protocols and reports, SOPs, batch records, method validation reports.
Interacts with direct report supervisors, customers and/or functional peer group managers and senior management.
May liaise with regulatory authorities.
Job Requirements:
Bachelor’s degree in a scientific discipline or equivalent.
Typically 7 years related experience in cGMP/FDA regulated industry.
Typically 3 years leadership experience.
Knowledge of cGMP/ICH/FDA regulations.
Proficient in MS Office applications.
Working Conditions and Physical Requirements:
Some travel may be required.
The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.