We are seeking a highly skilled and detail-oriented Regulatory Compliance Officer to join our team. As a Regulatory Compliance Officer, you will be responsible for ensuring that our organization complies with all relevant regulations and laws. You will play a crucial role in maintaining the integrity of our operations and protecting our reputation.
Duties:
Proficient in understanding product marketing categories in the USA and their associated regulatory requirements, encompassing OTC drugs, cosmetics, dietary supplements, medical devices, and general merchandise or household products.
- Well-versed in facility registrations and renewals processes.
- Expertise in reviewing product labels and claims to ensure compliance with respective product categories.
- Skilled in claim substantiation, including the ability to conduct scientific literature research, extract relevant information, comprehend findings, and create necessary substantiation documents.
- Experienced in product listing for various categories such as drug products (NDC), medical devices (GUDID), cosmetics (MoCRA), and dietary supplements (Structure function claims listing).
- Capable of creating and reviewing Drug facts, supplement facts, and nutritional fact panels.
- Collaborates with R&D, quality assurance, and other departments to seamlessly integrate regulatory requirements into product development processes.
- Interfaces with retailers or their assigned regulatory representatives to provide necessary regulatory information and documentation.
- Engages with global co-manufacturers during product development stages, offering evaluation and guidance as needed.
- Works with 3rd party laboratories or internal teams to oversee necessary testing for claim substantiation and/or development of supplement fact panels.
- Familiar with cGMPs, MoCRA, DSHEA, OTC Drug monographs, NDA, ANDA, OSHA, Prop-65, CPSC, EPA, USDA, medical device classifications and premarket notifications, TSCA, etc., and their respective requirements.
- Collaborates with cross-functional teams to streamline regulatory submissions and approvals.
- Interfaces with regulatory agencies, responding to queries and maintaining positive relationships.
- Ability to adapt to changing priorities and work on multiple projects simultaneously.
Requirements:
- Bachelor's degree in a related field (e.g., Chemistry, Life Sciences, or Business Administration)
- Strong knowledge of FDA regulations, particularly related to chemistry manufacturing controls, clinical trials, and quality assurance
- Proven experience in compliance management, preferably in the pharmaceutical or healthcare industry
- Excellent project management skills with the ability to prioritize tasks and meet deadlines
- Strong analytical and research skills to interpret complex regulations and apply them to our organization
- Attention to detail and strong problem-solving abilities
Benefits:
- Competitive salary based on experience
- Comprehensive health insurance package
- Retirement savings plan
- Paid time off and holidays
- Professional development opportunities
If you are a highly motivated individual with a passion for compliance and ensuring adherence to regulations, we encourage you to apply for this position. Join our team and contribute to the success of our organization while making a positive impact on public health.
Job Type: Full-time
Pay: $95,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Supplemental pay types:
Ability to Relocate:
- Buena Park, CA 90620: Relocate before starting work (Required)
Work Location: In person