Senior Regulatory Affairs Manager - Hybrid

We are seeking an experienced Senior Regulatory Affairs Manager to support a global beauty and wellness company in New York, NY.

This is a hybrid open to local candidates only.

Job Summary:

The Senior Regulatory Affairs Manager ensures regulatory compliance of the companys US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Sr. Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising. Communicate emerging regulations to key stakeholders and their impact on the US portfolio in NA.

Key Responsibilities:

• Ensure claims are compliant with the company and local regulatory requirements and consistent across labels, advertising, and other consumer communications
• Review and approve NA artworks
• Maintain and ensure compliance with the companys ingredient policies and appropriate product regulations
• Support with upcoming changes in the regulations including any specific monitoring and implementation for states, e.g., California
• Participate in project teams in assigned categories to ensure completion of appropriate documents during the development process through final formula approval and launch
• Responsible for US regulatory submissions, including FDA drug and establishment registrations, supplement notifications, WERCS and EPA and state pesticide registrations
• Assist monitoring US state and federal regulations impacting the cosmetic and personal care industry, including OTC

Requirements

Education:

• Scientific degree (MS or higher preferred)

Required:

• Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
• Experience communicating with cross-functional teams and customers, including verbal presentations
• Ability to meet deadlines while being flexible to changes in priorities and interruptions
• Excellent organizational and analytical skills to complete assignments accurately
• Full usability of MS Office suite (Excel, Word, Outlook, PowerPoint)
• Strong written communication skills, especially detail oriented and technical material
• Ability to work effectively both independently and as part of a team
• Over 8 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products including OTC

Preferred:

• Skin and personal care including OTC claim review experience
• Product development experience

Benefits

• PTO
• Dental
• Medical
• 401k
• Vision
• Holidays
• And more

The anticipated base pay for this position is $88,000 to $135,000. This range may be modified in the future and actual compensation may vary from posting based on geographic location, work experience, education and/or skill level. Employees may be eligible to participate in company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal, and family time off in accordance with the terms of the applicable plans.

An equal opportunity employer and we value diversity at our company. All aspects of employment are based on merit, performance, and business needs. We do not discriminate based upon race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

For more information about Hi-Quality Recruits, please visit https://hiqualityrecruits.com/