Regulatory Affairs Manager
Regulatory Affairs Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Who are we:
Cosmetic Solutions is a leader in the development and manufacturing of scientifically proven innovative personal care products. With a focus on face body hair OTC and professional use formulations we create some of the most cost effective high quality and powerful products on the market.
Providing world class services to up and coming businesses large established brands physicians estheticians and other skin care professionals; we specialize in research & development custom formalization graphic design manufacturing packaging and delivery.
Job Title: Regulatory Manager
Position Overview:
The Regulatory Manager in the Beauty & Personal Care Industry is a vital role responsible for ensuring compliance with regulatory requirements related to the development manufacturing and distribution of personal care products. This role involves staying current on industry regulations guiding product development teams and liaising with regulatory authorities websites and reference sources to provide the necessary approvals so that CSIL and our clients can enter production confidently. The Regulatory Manager plays a crucial role in navigating the complex landscape of beauty & personal care and US OTC regulations to ensure the organizations products meet legal and safety standards
Organizational Relationships
Reports to:
- Vice President of R&D and Regulatory
Key Responsibilities
- Regulatory and Compliance:
- Monitor and interpret local national and international regulations applicable to personal care and OTC product ingredient and labeling integrity.
- Interpret and communicate regulatory requirements to internal stakeholders clients and commercial resources in the GTM team.
- Develop implement and maintain strategies to ensure ongoing compliance with regulatory requirements for formulations.
- Strategy Development:
- Collaborate with cross-functional teams to develop regulatory strategies that align with business goals.
- Provide proactive regulatory awareness vs. reactive correction
- Product registration and Certification:
- Manage the preparation and submission of regulatory documents and product registrations to regulatory authorities.
1) NDC Organic registration WERCS MoCra registration for CS brands
- Liaise with regulatory agencies to obtain necessary approvals for new products and ensure timely renewals of existing ones.
- Work with certification providers and clients for certification of NSF Organic Vegan Gluten-free Reef-friendly ecocert etc.
- Liaise with GTM team resources regarding prioritization of work and whether or not there is a charge for certification work.
- Labeling and Claims Compliance:
- Ensure product labeling complies with regulatory requirements used in personal care and OTC products.
- Collaborate with suppliers to obtain necessary documentation and ensure ingredients and formula compliance.
1) PROP 65 non-nan IFRA Allergens etc.
- Validate formula claims.
1) Clean at Sephora Ulta Vegan Leaping Bunny
- Quality Management:
- Work closely with Quality Assurance and Compliance teams to integrate regulatory requirements in quality management systems.
- Support in quality audits and inspections related to regulatory compliance
- Risk Assessment and Mitigation:
- Conduct risk assessments for new product formulations at the beginning of the project. Review and validate PDRs with R&D.
- Provide guidance on mitigating regulatory risks associated with product development and manufacturing processes.
1) Master Formula Approval Packet review
- Liaison with external partners to provide necessary safety assessment documentation.
- Documentation and Record Keeping:
- Create and maintain accurate and organized regulatory documentation including product dossiers (PIF) and regulatory submissions.
1) QQF QIL manufacturing procedure formula SDS Certificate of Free Sale Letter of Authorization/Letter of Limited License
- Ensure that records are audit ready and accessible for regulatory inspections.
- Authenticate regulatory documentation required for customer product registration
- Communication and Training:
- Communicate regulatory updates to relevant departments.
- Develop and deliver training to educate cross functional teams on regulatory.
Equal Employment Opportunity
Cosmetic Solutions is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against on the basis of disability.
Required Experience:
Manager
Employment Type
Full-Time
