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Senior Regulatory Affairs Specialist (Beloit, WI)
The role of the Senior Regulatory Affairs Specialist is to manage regulatory, quality, and business issues to permit client 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 Client regulatory and quality strategy.
Responsibilities
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 RAC Certification, eCTD Submission, medical radioisotopes, and radiopharmaceuticals strongly preferred. Regulatory Affairs Certification (RAC) is preferred.
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.
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 client 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 client cross-functional teams, including but not limited to Quality Affairs, regarding client 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 Client business goals.
- Serve as the regulatory resource on client cross-functional teams in order to meet project target dates. Work with senior leadership to develop and update regulatory life cycles of client product offerings.
- Work with senior leadership to develop and update regulatory life cycles of Client 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 client policies and procedures.
- Review and approve (from a regulatory perspective) client drug product labeling and promotional materials (including but not limited to marketing materials, the client web site, and social media posts).
- Serve as the Regulatory Affairs point-of-contact for client senior management.
- Maintain current knowledge of, and ensure all client regulatory activities comply with, applicable regulations and guidance documents. Monitor and identify emerging regulatory and quality trends that may affect client.
- Develop and maintain as required internal regulatory standard operating procedures.
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 RAC Certification, eCTD Submission, medical radioisotopes, and radiopharmaceuticals strongly preferred. Regulatory Affairs Certification (RAC) is preferred.
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.
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