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Regulatory Affairs Manager

Position Purpose:
The incumbent provides regulatory oversight and support to his/her team's assigned products as well as direct input in areas of his/her expertise. The incumbent functions as the regulatory resource for the team's assigned products and is expected to monitor global regulatory agency publications, proposed guidances, inspection reports, and expectations to determine trends and areas of regulatory and compliance emphasis that could affect his/her products. S/he must have a working knowledge of all SOPs, CGMPs, ICH Guidelines, and Company Regulations that directly affect the position, JM products, and a firm familiarity with all others that affect the Company as a whole and that regulate the pharmaceutical industry. The incumbent is responsible for assisting during audits and inspections concerning his/her products. The incumbent has no direct line authority for any of the personnel in the departments in which he/she must assure regulatory compliance. To assure that adequate regulatory compliance is maintained without such line authority is the greatest challenge of the position. The incumbent's effectiveness is directly dependent on his/her skill in the use of "Reference Authority" and on his/her ability to forge consensus among groups and individuals having divergent agendas.
Compile, evaluate and file DMFs on behalf of Johnson Matthey. Assure site registrations and GDUFA fees are up to date.
Act as the Regulatory Project lead for assigned projects to recommend regulatory strategy and business commercialization timing.
Performs gap assessments and risk analysis on regulatory submissions to assure the balance of speed to file and Right-first time submissions are considered.
Functions as the Regulatory Compliance resource for facility and , to bring awareness of global regulatory agency expectations to the site improvement teams.
Keep up knowledge in regulatory areas which impact JM business areas through publications, proposed guidance's, inspection reports industry trendsin areas of compliance that could affect his/her assigned products. The incumbent is expected to proactively recommend courses of action to implement/improve JM compliance with new regulatory requirements for his/her assigned products.
Review and approve the development reports, control procedures, processing procedures, validations, test methodologies, equipment qualifications, and other required documentation which are necessary to both develop a product and also successfully transition it into routine commercial manufacture. The incumbent shall prepare and approve global regulatory submissions and technical packages for customers which describe the manufacturing and control procedures used to manufacture his/her assigned products. The incumbent must be able to successfully defend these documents when questioned during customer audits and regulatory agency inspections.
Advises management on the best course of action and preparing responses and correspondence.
Functions as a regulatory affairs representative for the Change Control, Deviation, Out of Specifications (OOS), and Trackwise?? systems for his/her assigned products.
Prepares annual reports to submit to the regulatory authorities for his/her assigned products.
QUALIFICATIONS, KNOWLEDGE, & EXPERIENCE ESSENTIAL
BS in Chemistry or related science with at least 5-10 years related experience in the pharmaceutical or API manufacturing industry; or a Master's degree in Chemistry or related science with 3-5 years related experience. Preferably a degree in Regulatory Affairs.
3-5 years experience in Regulatory Affairs, within the pharmaceutical or API industries.
Experience engaging with Board of Health regulatory authorities for issue resolution is a plus
Knowledge of High Potency and Controlled substances manufacturing and regulatory management is a plus.
Experience compiling DMFs, and LOA process or CEPs and variation process is a plus.
Is knowledgeable of the regulations pertaining to the API industry, including but not limited to ICH Q7 and related guidance's, FDA regulations, etc.
Understanding of Process Chemistry, method development, Analytical Testing and Product Commercialization
Clear and concise communication, both written and verbal
Proficient in word processing, database, spreadsheet, and electronic documentation and publishing software
Ability to work across functions to collaborate on regulatory strategy, and compilation of the multiple sections of DMFs or other regulatory filings
Organization skills with excellent attention-to-detail skills
Experience in Project Management with the ability to track and deliver multiple projects effectively and on-time.
Self-motivated and team player, with the ability to coach others in the documentation requirements of Regulatory Affairs
Able to influence others to meet compliance and commercial timelines.

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