Director of Regulatory and Compliance
Company: Michael Page
Posted on: June 17, 2022
The Director of Regulatory and Compliance will be responsible
for being the regulatory expert in keeping the company compliant
with regulatory requirements pertaining to OTC, Dietary Supplement,
Homeopathic, and Cosmetic product categories.Client DetailsMy
client has been in the the health and wellness industry for over
100 years, they focus on a variety of products that cater to
- Ensure all product packaging are in compliance with applicable
- Compile and maintain ingredient documentation (ex: Natural,
GMO, BSE, TSE, Organic, Sources, ingredient functionalities, etc.)
to ensure compliance supporting product claims and
- Partner with Marketing on claims and claim substantiation.
- Collaborate with marketing to ensure promotional material
content is supported by the Product Information, literature, and in
accordance with the regulatory guidance.
- Monitor the regulatory environment and keep the company
informed of regulatory changes (e.g., registration requirements,
Prop 65, organic, clean, natural guidelines).
- Manage and maintain company registrations, licenses, and
- Ensure compliance with local, state, and federal regulatory
- Complete and maintain product toxicity assessments.
- Complete product registrations (drug listing) and manage annual
product re-certifications (OTC).
- Complete and file Structure/Function Claims Notifications
- Partner with Sales to ensure retailers and distributors obtain
required product documentation (WRECS, ReposiTrak, ILs, SDS, COA
- Manager and complete Annual Product Reviews for OTC
- Manage complaint handling program and investigate product
quality complaints within specified timelines.
- Assess Adverse Events and ensure Serious Adverse Events are
reported to FDA/health authorities on time.
- Support product registrations in international markets.Profile
- Bachelor's or advanced degree in scientific field.
- 15+ years of experience in regulated industry (Pharmaceutical,
OTC, Dietary Supplement, Cosmetic, Medical Device or Food).
- 10+ years of progressive regulatory compliance experience
- Solid operating skills including timely decisions, managing,
and measuring work along with good overall time and project
- An effective leader who brings optimism and excitement to
others, with an ability to present himself/herself professionally
and confidently in large public forums, including representation in
the cosmetic community and at the senior levels of the government
and public community.
- Proficient in Word, Excel, and PowerPoint with the ability to
promptly learn and master regulatory/compliance software.
- In-depth knowledge of FDA regulations (pertaining to OTC,
Dietary Supplements, Food, Cosmetics) and ICH guidance documents
and other state and federal regulatory developments.
- Strong knowledge of OTC drug, Dietary Supplement, and Cosmetic
regulations and labeling requirements.
- Experience in electronic enterprise quality management and
- Demonstrate strong technical ability and skills in assigned
work area to include product, process and/or testing knowledgeJob
- Hybrid Schedule
- Base up to $180k
- Room for growth!MPI does not discriminate on the basis of race,
color, religion, sex, sexual orientation, gender identity or
expression, national origin, age, disability, veteran status,
marital status, or based on an individual's status in any group or
class protected by applicable federal, state or local law. MPI
encourages applications from minorities, women, the disabled,
protected veterans and all other qualified applicants.
Keywords: Michael Page, Torrance , Director of Regulatory and Compliance, Executive , Torrance, California
Didn't find what you're looking for? Search again!