Director Scientific and Regulatory Affairs

Overview

Job Description

Director Scientific and Regulatory Affairs will advance the success of existing products through best-in-class research, scientific content, and clinical substantiation

Anticipate and advise on future regulatory trends and direction and frequently recommend preemptive approaches for company regulatory compliance.

Lead all regulatory matters, including labeling requirements, domestic and international filings, FDA and FTC document submissions, and manage third-party consultants

Director Scientific and Regulatory Affairs will conduct timely and enhanced regulatory reviews to support commercialization of private label and custom product formulations

Liaise and foster relationships with government agencies and trade organizations. Advise on emerging policies and legislative matters

Director Scientific and Regulatory Affairs will assess market trends, relevant legislation, and consumer needs to ensure product compliance, relevance, and prominence

Manage and direct research and development programs to meet organizational needs and to capitalize on GHW’s various brands

Director Scientific and Regulatory Affairs will work closely with other departments (Legal, Quality, Procurement, and Distribution Center) to develop new product specifications that are compliant with the Code of Federal Regulations and compatible with GHW’s infrastructure

What We Offer

• Amazing opportunities for career progression
• Dynamic, fun, entrepreneurial and diverse culture
• Medical (Choice Plus or HSA) & Prescription Drug, Dental (DHMO or DPPO), Vision, and Ancillary options
• Health and wellness are a top priority – committed to self-care
• 401(k) (100% match (dollar-for-dollar) up to 6% of salary deferrals)
• 2 Company-Wide Breaks, Summer & Winter
• Generous Paid Time Off and Paid Holidays
• Volunteer Time
• Employer Paid Life Insurance, Short-Term Disability, Long-Term Disability,
• Health Savings Account (company contributes $65 monthly)
• Employee Assistance Program
• Business casual atmosphere – jeans and sneakers are okay by us

What You Bring to the Table

• Advanced degree in a relevant biomedical field required
• 7+ years of relatable professional experience
• Must have a strong background in the dietary supplement industry
• Bilingual (English / Spanish) is a plus
• Ability to understand, interpret, and draw valid conclusions from scientific literature, and evaluate the quality of scientific studies
• In-depth knowledge of the regulations that govern dietary supplement products and claims
• Strong technical expertise of research design, ethics, and statistical analysis
• Extensive knowledge of analytical assay methodologies, solid / liquid dose manufacturing process, and cGMP

EOE, DFWP

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