Director, Regulatory Affairs & Compliance

About Women's Health Bonafide, Uqora and Equelle comprise Pharmavite's Women's Health portfolio. Collectively, these brands are driven by their promise to champion women's health and joy at every age. Our People Our Women's Health team is composed of highly experienced professionals dedicated to making a meaningful impact. Bring your whole self to our Women's Health brands - you'll be welcomed by a team that shares your passion, purpose, and pride in our products while embracing your unique talents, creativity, and collaborative spirit. This role is not available for sponsorship, including I-983 participation. JOB DESCRIPTION The Director of Regulatory Affairs & Compliance will proactively focus on regulatory compliance of the Company's finished products sold in the US as well as advise on the regulatory classification for potential products within the Company's pipeline. The Director of Regulatory Affairs & Compliance will have a strong working knowledge of 21 CFR, including Parts 101, 110, 111, 117, 190, 201, 314, 329, 330, 701, 801, and 814, consult with outside consultants in less knowledgeable regulatory categories, and will identify regulatory gaps and work to close them. He/she will review the company policies and procedures to ensure they comply with federal, state and local regulatory guidelines. The Director of Regulatory Affairs & Compliance will also work closely with Quality, Legal, R&D, Sales, and Marketing departments, and will report to the Corporate General Counsel. RESPONSIBILITES

• Review product formulas and raw materials for compliance with applicable regulatory requirements, including ascertaining the regulatory classification of any proposed new products, and help generate new and updated product labels including food/supplement facts panel, ingredient statements and allergen statements ensuring compliance with regulations.
• Review and approve label artwork, graphics and text as well as marketing assets and website claims with a high level of detail for accuracy.
• Collaborate with multiple functions and support innovation projects and new product development.
• Monitor US and global regulatory legislation and provide the team with regular updates.
• Assist with the implementation of programs, policies, SOPs and practices to ensure products comply with appropriate regulations.

QUALIFICATIONS: In order to take on these challenges, you'll need to have:

• Minimum 10 years of experience in Regulatory within the dietary supplement and/or food industry.
• Working knowledge of Dietary Supplement Health and Education Act (DSHEA).
• Working knowledge of 21 CFR Parts 110, 111, 117, 190, 201, 314, 329, 330, 701, 801, and 814.
• Knowledge of current FDA and FTC guidance documents and enforcement policies within the food and dietary supplement industries. Experience managing FDA 510(k) and ANDA submissions a plus.
• Experience in working with finished products.
• Ability to understand and interpret clinical trial reports, medical journal articles and other medical/scientific materials that support product claims.
• Ability to read and interpret regulations, guidance documents, technical manuals, handbooks, formulations, and product specifications.
• Demonstrated ability to be proactive, independent, highly motivated, and effective in managing multiple projects, including outside consultants and counsel.
• Excellent communication skills with the ability to clearly communicate orally and in writing.
• Excellent planning, prioritizing and organizational skills.
• Highly proficient with corporate software tools - Microsoft office suite including Word, Excel, PowerPoint.
• Bachelor's degree or higher, preferably in life sciences or related area.

OUR OFFER Here, career paths aren't predefined, and bureaucratic limitations don't exist -- you have the opportunity to grow, learn from industry pioneers, and develop the way you want to. Our Women's Health brands are investing more in the development of our team -- to help us deliver on our purpose and help you achieve your career aspirations. Our environment is geared to fuel curiosity, encourage experimentation, and generate learning as this is the way we develop ourselves and our organization. We are committed to meeting the needs of our employees and their families with a Total Rewards package that's as comprehensive as the vitamins and supplements we deliver to consumers. With competitive compensation programs and standout benefits, we provide employees with optimal health and well-being -- as well as peace of mind. These rewards -- plus our new recognition program -- ensure employees feel supported both at work and home. SALARY RANGE National Target Base Pay Range: $143,000.00 - $239,000.00. The salary range for this position is based on national standards. For candidates in California and New York metro the Target Base Pay Range is $159,000 - $265,000, to reflect the cost of living and market conditions in those areas. Actual compensation will take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location, education, experience, qualifications and job-related skills. It is not typical for an individual to be hired above the midpoint of the range for their role and compensation decisions depend on the facts and circumstances of each case. This information is provided to applicants in accordance with state and local laws. Base pay is only one component of our total rewards offerings, and we will take the full offering into consideration when presenting an offer of employment. Our total rewards package for this position may also include an annual performance bonus, Medical, dental and vision benefits, 401K match, and other wellness benefits. T his represents the minimum and maximum base salary range for this role , plus annual incentive. Various elements are used to determine a candidate's starting salary such as job experience, specific skills, and comparison to internal incumbents currently in the role. This information is provided to applicants in accordance with state and local laws. Bonafide is an equal opportunity employer. We prohibit employment discrimination and harassment based on race, color, religion, age, sex, sexual orientation, gender, national origin, and any other basis protected by state and federal law. Bonafide recruits, hires, employs, trains, promotes, and compensates individuals solely based on job-related qualifications and abilities. Bonafide also provides reasonable accommodation to qualified individuals with disabilities or based on a sincerely held religious belief, in accordance with applicable laws. If you need to inquire about an accommodation to complete the application process, please email recruiter pharmavite.com . Disclaimer The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications of employees assigned to this job. CALIFORNIA FAIR CHANCE ACT: Qualified Applicants with arrest or conviction records will be considered for Employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. JOB ALERT FRAUD: We have become aware of scams from individuals, organizations, and internet sites claiming to represent Bonafide in recruitment activities in return for disclosing financial information. Our hiring process does not include text-based conversations or interviews and never requires payment or fees from job applicants. All of our career opportunities are regularly published and updated on Bonafide's Careers section. If you have already provided your personal information, please report it to your local authorities. Any fraudulent activity should be reported to: recruiter pharmavite.com . Apply tot his job Apply To this Job