Senior Regulatory Affairs Specialist

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, 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 Senior Regulatory Affairs Specialist 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. The Senior Regulatory Affairs Specialist will have primary responsibility to handle day-to-day activities related to FDA electronic submissions for drug marketing approvals. This role will also work with the Vice President, Quality and Regulatory to develop NorthStar regulatory and quality strategy.

Responsibilities

- Create and ensure appropriate 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 critical analyses, interpretation, and conclusions of technical, scientific, medical, clinical, and quality data; perform reviews of protocols and study reports.
- Collaborate with NorthStar cross-functional teams, including but not limited to Quality Affairs, regarding NorthStar regulatory and quality strategy through successive stages of medical radioisotope production development; apply and advance knowledge of U.S. and international regulatory requirements applicable to NorthStar business goals.
- Serve as the regulatory resource on NorthStar cross-functional teams in order to meet project target dates. Work with senior leadership to develop and update regulatory life cycles of NorthStar product offerings.
- Work with senior leadership 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 website, and social media posts).
- Serve as the Regulatory Affairs point-of-contact for NorthStar senior management.
- 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.

Qualifications

Bachelor's degree in the life sciences (i.e., biology, chemistry, physics) or engineering and minimum four (4) years of progressive regulatory and quality experience in the pharmaceutical industry; or equivalent combination of education and experience. Experience with RAC Certification, eCTD Submission, medical radioisotopes, and radiopharmaceuticals strongly preferred. Regulatory Affairs Certification (RAC) is preferred.

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position. Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment. Under federal law, only truthful information may be provided on the Form I-9.

Working Conditions

Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination.

The work environment may include exposure to a heated/air-conditioned indoor office/manufacturing/cleanroom setting with adequate ventilation and lighting and outdoor environments with varying temperatures. The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions. Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols. This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment. In addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders.

The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing.

Location

NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.

Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.

NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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