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Sr Manager, CMC - Global Regulatory Affairs (Biologics)

Company: Otsuka
Location: Manassas
Posted on: November 22, 2021

Job Description:

Job Description Provide CMC regulatory expertise in the area of investigational and marketed biologic products to assigned project teams. Establish CMC regulatory strategies for investigational and marketed biologics products. Ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances primarily 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 drug substances, drug products, and drug-device combination products.- Determine regulatory and scientific/technical requirements for CMC and GMP related submissions and inquiries.- Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.- 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.- 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.- Serves as the sponsor point of contact to the health authority for CMC related communications/ queries.- Participate in Health Authority CMC meeting preparations, rehearsals and/or meetings; Serve as Otsuka CMC RA representative at Health Authority meetings, as needed.- Monitor, interpret, and proactively assess developments in guidances, regulations, practices and policies in CMC and GMP areas.- Provide regulatory assessment in change management. - 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).- Effectively manages and directs internal support staff and external consultants for assigned projects.- 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.QualificationsKnowledge:- Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues.- Thorough knowledge of FD&C Act, 21 CFR, FDA and ICH Guidances, FDA policies and practices for drugs, devices and drug-device combinations. Similar knowledge of EMA, Latin America and middle-east countries will be a plus- 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- 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.- 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 plusExperience:- 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.- Knowledge of CMC regulatory requirements for biologics during development and post-approval. - Knowledge of pharmaceutical development, including biologic upstream and downstream processes, analytical methods, and biologic/device combination products. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Disclaimer:This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Come discover more about Otsuka and our benefit offerings; . Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status. Statement Regarding Job Recruiting Fraud Scams Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career website . Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.

Keywords: Otsuka, Alexandria , Sr Manager, CMC - Global Regulatory Affairs (Biologics), Executive , Manassas, Virginia

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