Senior Scientist/Associate Director, Regulatory Affairs CMC (Basking Ridge)

Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary:

This position manages multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO.
This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves as ad hoc member to the Global Project Team for late stage projects. This position manages multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO. This position develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (e.g., IND, IMPD, IB) and marketing applications/supplements & variations (e.g., NDA, BLA, MAA).

This position authors regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this position acts as the company liaison with the Health Authority (e.g., US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (e.g., preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from preparation of the briefing book, to training and preparing the technical team, to authoring and finalizing the meeting minutes.

This position develops awareness of global requirements through support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence, regulatory authority inspections). Additionally, this position has direct interaction with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some complexity. This position makes decisions with consultation.
Responsibilities:

• Planning for Development : Manages multiple CMC development projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.

• Execution of Strategy and Submissions: Develops strategy with supervision. Prepares content templates and leads technical team in preparation of submission documents; authors regulatory documents where necessary with supervision.

• Health Authority Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager.

• Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company initiatives.

Qualifications:

Education and Experience:

• Bachelor's Degree in Life Science required.

• M.S./PhD. preferred in a scientific discipline.

• MS Degree with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or

• PhD. with 6-8 years pharmaceutical industry experience and 4+ years direct or related CMC regulatory experience

• Successful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA

Competencies:

• Advanced knowledge of regulations/guidance documents with strong technical knowledge based upon academic training and job experience.

• Strong oral and writing skill.Able to write regulatory documents in highly complex technical areas.

• Ability to travel up to 10%, Global Travel

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.