Associate Director, Regulatory Affairs Strategy - Basking Ridge , New Jersey, United States, 07920
With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
- Responsible for managing the submission of IND's and NDA's for development practices.
- Represent Daiichi Sankyo's regulatory group in internal and external development project meetings.
- You will organize and coordinate submissions in accordance with applicable regulations and guidance, provide global development project meetings.
- Conduct completeness, scientific accuracy and ease of review of the submissions.
- You will provide guidance to peers and direct reports regarding regulatory issues.
- Prepare and review annual reports and supplements for marketed products. The Associate Director, Regulatory Affairs will liaise with the review branches of FDA throughout the review process of the submissions and represent Regulatory at FDA meetings (pre-IND, EOP2, Pre-NDA).
- This person will interface with clinical and pre-clinical groups, Regulatory CM&C and other appropriate group within the company as required.
- Manages, directs and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products.
- Supervises the identification and compilation of required documentation for submission. Prioritizes workload as necessary.
- Advises on submission strategy and evaluates the adequacy of the content of regulatory submissions and identifies deficiencies requiring further resolution.
- Evaluates the adequacy of the content of regulatory submissions and identifies deficiencies requiring further resolution.
- Assists and trains associates/managers in Regulatory submission and review activities.
- Prepares responses to requests from Health Authorities and acts as a key liaison with the FDA to schedule and lead meetings and carry out discussions and negotiations.
- Keeps current with latest Health Authority guidelines and provides Regulatory advice to members within Regulatory, and various associated departments within the Company. Also communicates with outside consultants (i.e. CRO's) as needed.
- Assures timely delivery of quality documents and represents the Regulatory department at GDT, project team and other meetings requiring Regulatory guidance and strategy.
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
- Minimum: a B.S. preferably in a scientific discipline.
- Preferred: an advanced degree (Masters, Pharm.D., Ph.D.).
- With advanced degree a minimum 5-7 years of relevant pharmaceutical experience including 2-4 years of experience within Regulatory Affairs. With a Bachelor's degree a minimum of 7+ years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs.
- Knowledge of IND, NDA and document management. Experience with EU CTA submissions a plus.
- Experience in providing regulatory strategic input into the drug development process.
- Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge of regulations, such as ICH is desirable.
- Experience with CTD/eCTD preparations preferred.
Associate Director, Regulatory Affairs Strategy
Regulatory Affairs Oncology