Pharmaceuticals, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
The function of a Manager, Regulatory Affairs is to manage regulatory and business issues to enable radiopharmaceutical products that are developed, manufactured, or distributed to meet required legislation. The Manager, Regulatory Affairs will have primary responsibility to oversee a group of Regulatory Professionals and manage day to day activities related to the submission of DMFs, ANDA/NDAs, related amendments and supplements, and acquire the appropriate marketing approvals while ensuring compliance with applicable FDA regulations. Secondary responsibilities will be to obtain appropriate international registration with appropriate competent authorities as required by company strategic planning.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
Supervise a Regulatory team on the content, format, style and architecture of New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Drug Master Files and related amendments and supplements and their strategies for gaining regulatory approval. Review submission sections and evaluate relative to development strategy and conformance with the regulatory requirements.
Contribute to multidisciplinary teams with respect to regulatory strategy for drug development including CMC, and commercial requirements through successive stages of development. Apply and advance knowledge of U.S. and international requirements/guidelines applicable to same.
Oversee global communications to Regulatory Authorities by the corporation on all aspects of a product offering: annual updates, responses to requests for information, in accordance with company policies and practices.
Contribute to multidisciplinary teams on the regulatory requirements for publically shown materials, including promotional materials.
Liaise with regulatory authorities and participate in/manage regulatory meetings with regulatory agencies.
Manage critical analyses of data (clinical, preclinical and manufacturing), interpretation, and conclusions; performs reviews of protocols and studies reports.
Maintain responsibility for the regulatory strategy related to CMC for life cycle maintenance of marketed and pre-market product offerings.
Ensure sufficient regulatory resources are applied to development teams to meet project target dates.
Oversee pre- and post-approval regulatory submissions including annual reports, renewals, supplemental applications, and briefing packages for regulatory authority meetings.
Serve as the contact for upper management concerning regulatory issues in the absence of the VP, RA/QA.
Manage the performance and development of staff as scope of responsibility expands. Maintains current knowledge of, and ensure all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
Train staff in regulatory policies or procedures.
Develop and maintain regulatory standard operating procedures or local working practices.
Oversee regulatory reviews of customer complaints to ensure effective and timely reporting of all complaint data.
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
Establish procedures or systems to support document submissions in electronic format.
Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.
Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon foot printing issues, or green policy implementation.
Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
Support NorthStar’s Quality System and Health & Safety Program by following policies and procedures.
Ability and willingness to travel, both domestically and internationally, up to 20% of the time between NorthStar locations.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor's Degree in the Physical Sciences and eight or more years’ experience in the pharmaceutical industry, with a minimum five to seven years in Regulatory Affairs and a minimum of four years of management experience over Regulatory Professionals is required; or equivalent combination of education and experience. Experience with Radiopharmaceuticals, RAC Certification, and eCTD Submission experience is preferred.
Proficient knowledge of Microsoft Office software programs, including Outlook, Word, and Excel. Experience with electronic (eCTD) publishing software preferred.
Excellent communication skills, verbal and written
Ability to work in a team environment, as well as independently
Ability to handle multiple tasks simultaneously
Ability to work in a fast-paced environment
Adaptable to change in the work environment
Internal Number: 01
About NorthStar Medical Radioisotopes
NorthStar Medical Radioisotopes is a nuclear medicine technology company committed to providing the United States with reliable and environmentally friendly radioisotope supply solutions to meet the needs of patients and to advance clinical research. The Company’s first product is the RadioGenixTM System, an innovative and flexible platform technology initially approved by the U.S. Food and Drug Administration in February 2018 for the processing of non-uranium/non-highly enriched uranium based molybdenum-99 (Mo-99), the parent isotope of technetium-99m (Tc-99m), which is currently the most widely used diagnostic radioisotope for medical purposes. NorthStar’s proprietary and patented technologies include non-uranium based molybdenum-99 domestic production methods, patented separation chemistry systems, patented sterilization systems and a technology platform that potentially allows expanded product offerings to provide solutions in both the diagnostic and therapeutic markets. Founded in 2006 and based in Beloit, Wis., NorthStar Medical Radioisotopes, LLC is a wholly-owned subsidiary of NorthStar Medical Technologies, LLC. For more information, visit: www.northstarnm.com.