Manager, Regulatory Affairs

Responsibilities

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).

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.

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.

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.

Requirements

Bachelor's degree in chemistry, Applied Science, or related field, required.

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.

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.