Kaztronix
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Regulatory Affairs Manager IV
Princeton, NJ US
Posted: 09/06/2023
2023-09-06
2023-10-29
Industry: Scientific
Job Number: 23-00423
Job Description
CW CMC Regulatory Affairs Manager role
Role Description
Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing.
Position Responsibilities Include:
- Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances, drug products, and drug-device combination products.
- Determine regulatory and scientific/technical requirements for CMC and GMP related submissions and inquiries.
-Represents CMC RA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with global regulatory lead(s).
- Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements.
- Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.
- Provide regulatory assessment in change management.
- Develop and maintain collaborative relationships with other local and/or global functional units [OPCJ CMC RA, Factory, Quality, MPDD, OPDC/OPEL Tech Ops] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc.
- Participate in Health Authority CMC meeting preparations, rehearsals and/or meetings.
- Assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.
- Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Trackwise, Concur (expenses), and Powerpoint.
- Performs other duties as assigned.
Qualifications
Knowledge:
- Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues.
- Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products.
- Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canda
- Comprehensive understanding of the global regulatory environment.
Skills:
- Proactive strategic thinker
- Operationally minded (know how to prepare a high quality technical document or submission using internal systems
- Strong analytical, problem solving, organizational and negotiation skills.
- Strong collaborative inter-personal, communication, presentation and meeting leading skills.
- Strong ability to work in matrixed environment and across cultural lines.
- Strong ability to independently manage and prioritize a multi-project load
- Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word,
- Excel, PowerPoint, and Outlook).
Education:
- Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., Masters and Ph.D. Preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology
- RAC certification a plus
Experience:
- 5 to 7 years or more of CMC regulatory experience in the pharmaceutical industry with a history of successful of investigational filings and approvals of marketing applications as the CMC Regulatory lead.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
Role Description
Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing.
Position Responsibilities Include:
- Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances, drug products, and drug-device combination products.
- Determine regulatory and scientific/technical requirements for CMC and GMP related submissions and inquiries.
-Represents CMC RA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with global regulatory lead(s).
- Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements.
- Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.
- Provide regulatory assessment in change management.
- Develop and maintain collaborative relationships with other local and/or global functional units [OPCJ CMC RA, Factory, Quality, MPDD, OPDC/OPEL Tech Ops] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc.
- Participate in Health Authority CMC meeting preparations, rehearsals and/or meetings.
- Assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.
- Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Trackwise, Concur (expenses), and Powerpoint.
- Performs other duties as assigned.
Qualifications
Knowledge:
- Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues.
- Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products.
- Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canda
- Comprehensive understanding of the global regulatory environment.
Skills:
- Proactive strategic thinker
- Operationally minded (know how to prepare a high quality technical document or submission using internal systems
- Strong analytical, problem solving, organizational and negotiation skills.
- Strong collaborative inter-personal, communication, presentation and meeting leading skills.
- Strong ability to work in matrixed environment and across cultural lines.
- Strong ability to independently manage and prioritize a multi-project load
- Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word,
- Excel, PowerPoint, and Outlook).
Education:
- Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., Masters and Ph.D. Preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology
- RAC certification a plus
Experience:
- 5 to 7 years or more of CMC regulatory experience in the pharmaceutical industry with a history of successful of investigational filings and approvals of marketing applications as the CMC Regulatory lead.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.