Manager, Regulatory Affairs

Overview

Accelerate your career with NorthStar!

 

NorthStar Medical Radioisotopes is seeking individuals with a desire to work within the pharmaceutical industry who possess an Intense Customer Focus, are Proactive and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner.  We are a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer along with customized radiopharmaceutical development services.

 

At NorthStar, we prioritize professional growth of our employees. Working with our cutting-edge technology offers a stimulating and rewarding environment for talented individuals who want to be part of our exciting and growing business. We are committed to providing our employees with fulfilling work experiences and valuable career development opportunities. 

 

Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, paid parental leave and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

Position

The role of the Manager, Regulatory Affairs is to manage regulatory, quality, and business issues to permit NorthStar to develop, produce, and distribute medical radioisotopes and radiopharmaceuticals that comply with U.S. Food and Drug Administration (FDA) and other applicable requirements.  This role also includes supporting the management of regulatory, quality and business issues for our sponsors (Contract Drug Manufacturing Organization customers) to develop, produce, and distribute drug products that comply with U.S. Food and Drug Administration (FDA) and other applicable requirements. The Manager, Regulatory Affairs will have primary responsibility to manage a team of regulatory professionals who handle day-to-day activities related to FDA electronic submissions for drug marketing approvals. The Manager, Regulatory Affairs also will work with the Vice President, Regulatory Affairs (VP, RA) to develop NorthStar regulatory and quality strategy and to ensure that the Regulatory Affairs professionals are developing new and overlapping skill sets.

 

Please note:  This role will be a future leader of the RA team.  You will play a key role in building the team you will eventually lead.  In the interim, you will be responsible for owning the function and handling all day-to-day responsibilities. 

Responsibilities

• Build and lead a team of regulatory professionals on the content, format, style, and architecture of FDA electronic submissions (including but not limited to NDAs, ANDAs, PASs, DMFs, adverse event reports, post-marketing study reports, and annual reports); review and evaluate submission sections in the context of NorthStar business goals and applicable regulatory requirements.
• Manage performance and professional development (including ongoing training) of regulatory affairs team as scope of responsibility expands.
• Handle and manage critical analyses, interpretation, and conclusions of technical, scientific, medical, clinical, and quality data; Perform reviews of protocols and study reports.
• Collaborate with NorthStar customers and cross-functional teams, including but not limited to Quality Affairs, regarding NorthStar regulatory and quality strategy through successive stages of medical radioisotope production and drug development; apply and advance knowledge of U.S. and international regulatory requirements applicable to NorthStar business goals.
• Assign sufficient regulatory resources to NorthStar cross-functional teams in order to meet project target dates.
• Work with VP, Quality & Regulatory to develop and update regulatory life cycles of NorthStar product offerings.
• Work with VP, Quality & Regulatory to manage and oversee communications, including in-person and virtual meetings, with the FDA and other regulatory authorities in accordance with NorthStar policies and procedures.
• Review and approve, from a regulatory perspective, NorthStar drug product labeling and promotional materials (including but not limited to marketing materials, the NorthStar web site, and social media posts).
• Serve as the Regulatory Affairs point-of-contact for NorthStar senior management when the VP, Quality & Regulatory is unavailable.
• Maintain current knowledge of, and ensure all NorthStar regulatory activities comply with, applicable regulations and guidance documents. Monitor and identify emerging regulatory and quality trends that may affect NorthStar.
• Develop and maintain as required internal regulatory standard operating procedures.
• Work with V