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CMC Regulatory Affairs Manager

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

Comprehensive knowledge of drug development, GMP requirements, and regulatory environment., Experience in preparing CMC sections for regulatory submissions, including FDA, Europe, and Canada standards..

Key responsabilities:

Develop strategies for CMC scenarios, prepare regulatory documents, manage submissions, and assess change management.
Represent CMC RA in project meetings, collaborate with cross-functional teams, and optimize departmental processes.

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

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.

Requirements:

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.
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).
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
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.