Title: Manager, Regulatory Affairs

Position Summary

The Manager, Regulatory Affairs will be responsible for managing regulatory requirements and in-market product compliance to maintain and further develop the regulatory capability of the US-based regulatory team for Alchemee (previously The Proactiv Company). This position will also cover Canada, Japan and other international markets to implement and contribute to creating global processes and systems. The Manager, Regulatory Affairs serves as the domestic and global regulatory contact at Alchemee. This role is expected to establish and build a full collaborative partnership with internal teams in support of Alchemee business needs.

This role will provide leadership in identifying regulatory and legislative issues that have the potential to impact the development and marketing of products. Provides strategic input and tactical support to project teams throughout the product lifecycle, with the goal of empowering informed decision-making to bring products to the market and maintain their availability.

Essential Functions

• Lead US OTC and Cosmetic and global regulatory functions and partner with business to drive growth ambition.
• Serving as the Regulatory representative on specific multi-discipline teams, may be responsible for organizing and leading meetings.
• Establishes efficient integration of regulatory support into R&D, technology/product development, marketing and business processes.
• Ensures all governmental reporting systems and documentation comply with applicable regulatory standards and requirements for OTC drug, cosmetic, consumer and other products.
• Work with internal and external companies to ensure appropriate regulatory framework is in place to ensure end to end regulatory compliance (e.g. cGMP, labeling, advertisement/promotional, claims etc.)
• Provides regulatory management and interface with regulatory authorities in case of issues, audits, quality incidents, market recalls, and any regulatory challenges.
• Lead with legal counsel to resolve product compliance conflicts, and other issues when ambiguity exists in the regulations by applying risk management principles to ensure consumer and brand protection.
• Manages the regulatory affairs associates daily workload; including dossiers, PIF’s, filing of license applications, product registrations renewals and annual reports with regulatory agencies, when required.
• Assists international regulatory support operations with Japan and Quasi drug license support and process, Health Canada and other international markets.
• Supervises the Canada market and Health Canada regulations as it related to TPC Canada business.
• Provides regulatory guidance as it relates to retail, direct to consumer, business to business and WERCs.
• Oversee FDA detention holds, custom holds, and border patrol and/or port product hold issues.
• Other duties as assigned.

Qualifications

• • Bachelor's degree in Chemistry, Applied Science, or related field, required.
• • Master's degree in Chemistry, Biology, Toxicology, Pharmacology or equivalent preferred.
• • Five to Eight years of experience in the regulatory function on cosmetic/personal care, skin care, pharmaceutical or manufacturing industry experience.
• • Demonstrated leadership skills in the areas of managing teams, driving results, team collaboration, mentoring and coaching, problem solving, and communication across functional areas.
• • Previous experience with pharmaceutical (Rx/OTC) manufacturing and skin care is a plus.
• • Working knowledge of products, formula (INCI), regulatory labeling and claims for OTC, monograph products and skincare cosmetics, including federal, state, consumer product safety commission and EPA.
• Strong knowledge/application of US FDA regulations, Health Canada regulations, EU/Brexit regulations, Japan (MHLW) regulations, PMDA, Prop 65, guidance documents and validation requirements.
• • Expertise in Cosmetic/OTC raw material ingredients safety and regulations.
• • Demonstrated ability to work independently and practically, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
• • High proficiency with software applications like Excel, PowerPoint, Word, PLM, QMS systems and PCPC.
• • Experience in international product introductions, including international compliance, global product and formula percent limitations and release requirements.
• • Provide regulatory guidance, risk assessment, and management throughout the product lifecycle: New Product Development and Commercial projects.
• Providing input to Standard Operating Procedure documents to ensure accuracy and compliance, as appropriate

The presently-anticipated base compensation pay range for this position is $107,500 to $131,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.