Senior Regulatory Affairs Consultant - CMC Biologics

Incredible opportunity to bring your experience leading CMC Regulatory strategies and your Biologics expertise to Parexel!

In this highly visible role, you will partner with a large, global pharmaceutical company and 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 client's 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.

- Develop and execute regulatory strategies for post approval changes for marketed products and communicate with respective cross-functional teams. Providing regulatory strategies on CMC changes for development phase products.

- Prepare departmental job procedures.

- Experience in CPP application filing through eCATS, 510(j)(3) reporting through nextGen portals is a plus.

- Interact with manufacturing and quality groups, partner organizations, regarding CMC issues.

- Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and reports within company timelines and in accordance with regulations and guidelines.

- Develop and maintain collaborative relationships with other local and/or global functional units 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.

- Independently handle monthly meetings with global cross-functional teams for assigned products.

- Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Trackwise, TRS Viewer, 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:

- 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.

- Regulatory experience in handling-controlled substance applications will be a plus.

- A proven track record of experience with biologic submissions is required, small molecule experience is also highly preferred, previous device experience is a plus.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.