Sr. Director, Regulatory Affairs Strategy
Princeton, New JerseySenior Director, Global Regulatory Affairs Strategy
The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsible for all associated regulatory filings.
Responsibilities
- Develop and execute novel drug regulatory strategy
- Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
- Strong project management skills and strong interpersonal skills to handle complex distributed programs
- Ability to author clear and concise regulatory documents with oversight of all documents for regulatory submissions and associated messaging
- Work closely with regulatory CMC lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are aligned
- Be the point of contact between the company and the regulatory agency – serve as the regulatory liaison for the company
Qualifications
- Master’s degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is mandatory; PhD or PharmD in above disciplines are preferred
- 10+ years industry experience a must with RA novel drug development
- CMC and/or Botanical experience, RAC certification
- Thorough understanding of ICH and US CFR requirements and regulations.
- Regulatory document submissions authoring experience (INDs, IMPDs, NDAs, BLAs, briefing books)
- Regulatory agency direct interaction experience
- Strong communications skills
About Us
Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S. We are the eighth-largest generics pharmaceutical company in the U.S., and we are rapidly ramping up our presence in the specialty branded market, with dermatology, ophthalmology, and oncology as key target segments.
Our Values
Sunology, a combination of Sun and Ideology, is the way of life at Sun Pharma. We practice humility, integrity, passion, and innovation.
How We Work
With people at our core, Sun Pharma has built an inclusive and collaborative work culture, where all employees are empowered to pursue their dreams and professional aspirations.
Benefits
-
Health & Wellness
We offer comprehensive benefits, including medical, dental, and vision coverage, as well as health and wellness programs.
-
Financial
We provide a competitive 401(k) match program and financial wellness programs to support our employees’ short- and long-term financial goals.
-
Life, Work & Family
We provide work-life benefits that support our employees beyond their workday.
-
About Us Learn more
-
Career Areas Learn more
Jobs for You
- Associate MRO Brampton, Ontario
- Reviewer, Documentation Quality Control Brampton, Ontario
- Technician-I, Packaging Brampton, Ontario
You have no recently viewed jobs.
You have no saved jobs.
Get Job Alerts
Sign up below to receive job alerts, our monthly newsletter, and advice from our recruiters straight to your inbox.