Sr. Manager Regulatory Affairs

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-disciplinary teams, may be responsible for organizing and leading meetings. Establishing efficient integration of regulatory support into R&D, technology/product development, marketing and business processes.
• Other duties as assigned.
• Provides regulatory advisement and interface with regulatory authorities in case of audits, quality /regulatory incidents, market recalls, and any other regulatory challenges.
• Ensures FDA and all other regulatory authority reporting systems and documentation comply with applicable regulatory standards and requirements for OTC drug and cosmetic skincare products.
• Lead along with legal counsel to resolve product compliance, packaging/labeling conflicts, claims substantiation and other issues when ambiguity exists in the regulations by applying risk management principles to ensure consumer and brand protection.
• Assists international regulatory compliance and support operations as it relates but not limited to; Health Canada, Australia, Japan, EU/UK, Singapore, Mexico and any other international markets.
• Manages the regulatory affairs associates team and advises on daily workload, including dossiers, PLM, PLC’s, label claims, Veeva, Prop 65, PIF’s, filing of license applications, product registrations renewals and annual reports with US and International regulatory agencies.
• Work with internal and external including international to ensure appropriate regulatory framework is in place to ensure end to end regulatory compliance as it relates to cGMP, labeling, PLCs, advertisement/promotional, claims, product registration, formula review, technical transfers, reformulations and new product development.
• Provides regulatory guidance and support as it relates to retail, direct to consumer, business to business, WERCs registration, international responsible person teams, vendors, etc.

Education, Knowledge, Skills, & Abilities

• Master's degree in Chemistry, Biology, Toxicology, Pharmacology or equivalent preferred.
• Eight (8) or more years of experience in the regulatory function on cosmetic/personal care, skin care, pharmaceutical or manufacturing industry experience.
• Working knowledge of products, formula (INCI), regulatory labeling and claims for OTC, monograph products and skincare cosmetics, including federal, state, PCPC, consumer product safety and federal trade commission and EPA.
• Bachelor’s degree in Chemistry, Applied Science, or related field, required.
• Previous experience with pharmaceutical (Rx/OTC) manufacturing and skin care is a plus.
• Experience in international product introductions, including international compliance, global product and formula percent limitations and expertise in OTC/cosmetic raw material ingredients and prohibited raw materials.
• Demonstrated leadership skills in the areas of managing teams, driving results, team collaboration, mentoring and coaching, problem solving, and communication across functional areas.
• High proficiency with software applications like Excel, PowerPoint, Word, PLM, QMS systems and PCPC, ESG Gateway and SPL.
• Demonstrated ability to work independently and practically, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.

Providing input to Standard Operating Procedure documents to ensure accuracy and compliance, as appropriate.

Salary range of $130,000 to $148,000 based on experience and qualifications, as well as geographical market and business considerations.