Senior Associate, Regulatory Affairs

Senior Associate, Regulatory Affairs

This Senior Associate, Regulatory Affairs role is responsible for independent execution of regulatory activities for defined products, work streams, or deliverables within the US OTC portfolio. This role will also serve as a specialist in regulatory processes and systems, supporting cross-brand delivery across the US OTC portfolio. The position ensures efficient, compliant execution of submissions, labeling, and maintenance activities, while leveraging regulatory systems, tools, and standardized processes to enable innovation and sustain compliance.

The position contributes to regulatory strategy development while independently delivering assigned regulatory activities, ensuring compliance and timely execution. Operates with guidance on complex issues and escalates risks appropriately.

• Deliver routine regulatory activities for assigned products or work streams
• Contribute to the development of regulatory strategies by analyzing regulations, precedent, and product-specific considerations
• Translate strategic direction into execution of defined deliverables
• Ensure timely execution of regulatory activities by tracking deliverables, communicating progress and escalating issues
• Provide operational expertise and cross-brand support of regulatory systems, tools, and processes
• Execute activities within regulatory information management systems (RIMS) and document systems
• Maintain regulatory records, databases, and trackers to ensure data accuracy, completeness, and inspection readiness
• Identify and implement process improvements or standardizations

• Operates as an independent contributor on project teams
• May provide informal mentorship or guidance to junior associates
• Builds strong cross-functional relationships within assigned teams

• This role is primarily internally facing. Because this role largely deals with regulatory strategy and compliance, impact can be broad within the US business. Strong organizational skills with out-of-the-box thinking is a must.

• Bachelor's Degree in Pharmaceutical or Life Sciences, Chemistry, Biology, Medicine, or similar discipline
• 2–4 years regulatory experience
• Strong understanding of US FDA regulatory frameworks
• Experience supporting regulatory submissions (OTC, NDA, or related)
• Excellent communications skills, stakeholder management and enjoys working in multidisciplinary teams

• Advanced degree or professional certification
• Experience working within cross-functional project teams
• Demonstrated ability to manage multiple deliverables independently
• Growth Mindset, with a love of learning and focus on what is possible
• Bias for Action and comfort with fast pace
• Interest and capability in applying AI and digital tools to modernize regulatory processes and improve efficiency.

Location:

This role is hybrid based in Warren, NJ with in-office requirements of 3 times per week.

Compensation:
The salary range for this role is: $87,575 - $120,415 plus an 8% on-target annual bonus.