Head of Regulatory Affairs

Company Description

ISDIN is an international leader in dermatology, offering innovative solutions for skin care, maintenance, and prevention. Founded in 1975 working closely with dermatologists and pharmacists, gaining extensive expertise in addressing various skin conditions. With a portfolio of renowned brands, the company focuses on advanced research and innovation to develop cutting-edge products. As a market leader in Spanish dermatology, ISDIN continues to expand its presence in Globaly.

Role Description

ISDIN is seeking a full-time Head of Regulatory Affairs for the USA Affiliate to be based on-site in Morristown, NJ. The role involves contributing to the development of the Company by managing from a regulatory and technical perspective, all activities related to the registration, compliance, and lifecycle management of products (OTC drugs, cosmetics, and medical devices) in the United States, ensuring alignment with FDA requirements and business objectives.

Key responsibilities include:

• Assume, jointly with Corporate Regulatory Affairs, the regulatory responsibility for all products marketed, under development, or planned in the US, ensuring full lifecycle management (submissions, updates, renewals, labelling).
•  Lead regulatory strategy and execution for FDA-regulated products, including OTC drugs (e.g., sunscreens), cosmetics , and medical devices (if applicable). 
• Ensure compliance with FDA regulations, including labelling, claims, post-market requirement and formulation reviews.
•  Provide regulatory guidance to cross-functional teams (Marketing, Medical Affairs, R&D, Supply, and Legal).
•  Evaluate licensing and partnership opportunities from a regulatory standpoint (dossier quality, timelines, feasibility, sales state licenses). 
•  Monitor regulatory changes (FDA, MoCRA, OTC monograph updates) and communicate their impact internally.
•  Maintain relationships with regulatory authorities, industry associations, and key stakeholders when relevant. 
• Support development of compliant and substantiated product claims in collaboration with Medical and Marketing teams.
• Contribute to the company´s science-based positioning by translating clinical evidence into compliant consumer messaging. 
• Ensure pharmacovigilance/cosmetovigilance and post-market surveillance activities according to US requirements. 
• Prop 65 Compliance CA

Qualifications

• Bachelor's or advanced degree in Pharmacy, Health and or Life Sciences, or a related field.
• Minimum 7 years in Regulatory Affairs in the US market. Experience with FDA.
• Proven experience in regulations (OTC drugs, cosmetics, and/or medical devices), lifecycle management, and labelling compliance 
• Experience in creating and implementing Regulatory Strategies for pharmaceutical or dermatology products.
• Proficiency in managing Regulatory Submissions, including preparation, review, and end-to-end tracking processes.
• In-depth knowledge of Regulatory Requirements and best practices for regulatory affairs management.
• Strong leadership skills, with experience managing cross-functional teams and projects.
• Excellent organizational skills and detail orientation.
• Strong communication and interpersonal skills to collaborate with internal and external stakeholders effectively.
• Manage registry software, word, lotus notes, explorer, excel etc…    

Other Added Values:

•  Strong knowledge of FDA regulatory frameworks, strategic mindset, crossfunctional collaboration, strong communication skills, high scientific rigor 
• Experience in dermatology, skincare, or OTC drug environment. 
• Experience with MoCRA and sunscreen monograph 
• Experience with clinical evaluation, claims substantiation, and industry networking 
• Advanced degree or Pharmacy, Chemistry, or related field specialization in Regulatory Affairs 
• Basic Spanish (plus)

Innovation, curiosity, emapathy, collaboration and inclusion are some of the characteristics that define us and that we seek in our ISDIN Talent community. Therefore, if you are always striving to give your best, eager to experience new things, believe sustainability is essential, and you are a socially commited person, please share your professional experience with us and join ISDIN USA!