Regulatory Affairs Manager / Sr. Manager
Regulatory Affairs Manager / Sr. Manager
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Job Description
Location: Nashville TN (Hybrid); Remote is available if not local
Travel: If working remotely travel is expected once every 1 month to Nashville TN.
We are a fast-growing innovative company that is revolutionizing global health. We have a dynamic team that is passionate about improving the lives of people by delivering premium healthy products through world-class research innovation and manufacturing.
POSITION SUMMARY:
We are seeking an innovative and detail-oriented Regulatory Affairs Manager or Sr. Manager to join our team and champion regulatory excellence in the cosmetics and dietary supplements industry. In this role you will play a vital part in ensuring that our products comply with all relevant regulations and standards providing both our consumers and business partners with confidence in the safety and efficacy of our offerings.
ROLES AND RESPONSIBILITIES:
- Serve as the primary point of contact for regulatory inquiries from consumers retailers and business partners providing accurate and timely responses to questions regarding product compliance.
- Conduct thorough reviews of product formulations claims artwork labeling packaging and marketing materials including digital & social media to ensure compliance with city county state federal and country regulations including FDA Canada EU SQF NSF and other applicable standards.
- Partner with internal teams to develop regulatory roadmaps to expand into new regions and markets while ensuring compliance.
- Collaborate with cross-functional teams including R&D manufacturing and marketing to ensure products including cosmetics & dietary supplements meet regulatory requirements from concept to launch.
- Monitor changes in regulations and industry standards and proactively advise internal stakeholders on potential impacts and necessary actions.
- Collaborate with QA/QC and Manufacturing to ensure all documentation and processes meet all regulatory requirements including management of product dossiers.
- Maintain up-to-date knowledge of regulatory changes and industry trends proactively advising internal stakeholders on potential impacts and opportunities.
- Partner with external regulatory consultants and agencies as needed to support regulatory submissions and compliance activities.
- Develop and deliver training programs on regulatory compliance for internal teams empowering them to uphold our commitment to quality and compliance.
- Monitor and track regulatory metrics and key performance indicators identifying areas for improvement and implementing best practices to enhance regulatory efficiency and effectiveness.
REQUIREMENTS:
- 10 years of experience in regulatory affairs and nutrition in CPG industry at Manager level; 15 years of experience at the Sr Manager level
- Bachelors degree in food science nutrition or related field is highly preferred
- Proven experience in regulatory compliance: cosmetic & dietary supplements mandatory
- Experience with OTCs medical devices or pharmaceuticals is preferred
- Prior experience working on new products and/or execution of new products is preferred
- Superb analytical skills with the ability to interpret complex regulatory requirements and assess their impact on business operations.
- Excellent communication skills with the ability to convey technical information clearly and concisely to both technical and non-technical audiences.
- Detail-oriented with high organizational skills and the ability to manage multiple priorities in a fast-paced environment.
- Knowledge of regulatory frameworks such as FDA SQF HACCP and industry-specific regulations.
- Follows closely with developing laws regulations and enforcement activities impacting the use of ingredients product safety labeling and advertising to provide effective regulatory assessment and impact of proposed changes to the business
- Proficiency in Microsoft Office Suite and compliance management software.
PHYSICAL DEMANDS / WORK ENVIRONMENT:
- Must be able to sit/stand for 8 hours.
- Base salary bonus base on company and personal performance
- Medical Dental Vision and Supplement insurance programs with company assistance
- 401(k) with company match
- Paid Time off Paid Holidays
COMPENSATION BENEFITS
- Base salary bonus base on company and personal performance
- Medical Dental Vision and Supplement insurance programs with company assistance
- 401(k) with company match
- Paid Time off Paid Holidays
Required Experience:
Manager
Employment Type
Full Time
