Regulatory Affairs Manager

Job Overview We are looking for a proactive and detail-oriented Regulatory Affairs Manager to join our dynamic team. In this role, you will be the key driver in ensuring our products meet all regulatory standards and compliance requirements across various markets. You'll work closely with research, quality assurance, and manufacturing teams to navigate complex regulations, prepare documentation, and support product approvals. The ideal candidate is passionate about regulatory science, thrives in a collaborative environment, and is eager to make a meaningful impact on product safety and compliance. Duties Lead the preparation and submission of regulatory documents to health authorities, ensuring timely approvals for new products and variations. Monitor evolving regulations such as FDA (Food and Drug Administration) guidelines and ensure company compliance across all stages of product development. Collaborate with research teams to review clinical trial protocols and data for regulatory submission purposes. Manage compliance documentation related to chemistry, manufacturing, and controls (CMC) processes to guarantee product quality and safety standards. Develop and implement strategies for regulatory pathways that facilitate product launches in different markets. Oversee internal audits related to quality assurance and compliance management systems. Provide training and guidance to cross-functional teams on regulatory requirements and best practices. Skills Strong knowledge of

FDA/USDA

regulations, clinical trial processes, and global regulatory frameworks. Experience with chemistry, manufacturing & controls (CMC) documentation and procedures. Excellent project management skills to coordinate multiple submissions and deadlines efficiently. Background in research or scientific fields related to pharmaceuticals or biotech industries. Ability to interpret complex regulations into clear action plans for teams. Familiarity with quality assurance processes and compliance management systems. Effective communication skills to liaise with regulatory agencies, internal teams, and external partners. Join us as a Regulatory Affairs Manager where your expertise will help shape the future of innovative products while ensuring they meet the highest safety standards worldwide!

Pay:

$90,000.00 - $110,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance Application Question(s): Do you have experience in

USDA/FDA CPG

products

Work Location:

In person