This position will be intimately involved in the development of the regulatory strategy to obtain early approval of product in development at Spectrum. She/he will manage the compilation and production of various regulatory submissions for biologic and small molecule products from the clinical perspective according to program timelines and in compliance with established submission standards, including eCTD requirements. Other activities will include providing input at Team levels regarding clinical regulatory strategy for the products and managing activities associated with clinical FDA-Sponsor meetings.
RESPONSIBILITIES:
- Develop the regulatory strategy and establish the registration requirements under the guidance of the Global Head of Regulatory Affairs
- Manages activities to compile and organize clinical data and documentation for INDs, CTAs, NDAs, and BLAs, as well as associated amendments, supplements, annual reports and expedited safety reports for US and global submissions
- Manages activities related to clinical FDA-Sponsor and/or other authorities’ meetings
- Review and approval of submission documents, including clinical study protocols and reports, statistical analysis plans, investigator brochures, aggregated safety reports and other documents as needed
- Represents Regulatory Affairs in Product Development Team Meetings
- Performs other related duties as required and assigned by Global Head of Regulatory Affairs.
Required Skills
- Excellent knowledge of U.S. and global regulations and guidance documents
- Comprehensive understanding of pharmaceutical business, including R&D organizations
- Demonstration of positive interaction skills with excellent work ethics
- Proven oral and written communication skills, including presentations to various external groups and authorities
- Excellent organizational skills
- Must be able to work independently and in a team environment
- Ability to manage multiple tasks simultaneously
- Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat is required
- RAC certification or regulatory affairs degree is preferred
Required Experience
- Bachelor’s degree required, with an advanced degree in science (MD, PhD, PharmD) preferred
- Minimum 10 years of related experience in the pharmaceutical industry
- Demonstrated successful experience related to the compilation, production and submission of regulatory dossiers relating to clinical sections in eCTD format, including US and rest of world applications