Senior Manager, Regulatory Affairs, OTC (CMC)

Job Title: Senior Manager, Regulatory Affairs, OTC

Duration: 6 Months (possible extension or conversion into FTE)

Location: Warren, NJ 7059 (Hybrid- 3 days)

Shift: 8am-5PM

Job Purpose

The purpose of this role is to execute OTC regulatory activities for new product registrations and life-cycle maintenance for the portfolio of products defined by the US Business Units.

Key Responsibilities

These responsibilities include some of the following:

• Ensures cross-portfolio aligned regulatory strategy to deliver timely approvals for US submissions and OTC Monograph product launches.
• Develop and implement regulatory strategies and documents for new product launches and maintenance of current products aligned with the regulations.
• Support key processes and ways of working, regulatory labeling and artwork review, aligned with local requirements.
• Support the development of claims, advertising, and promotion within the regulations, ensuring risks are appropriately addressed and communicated.
• Prepares registration files, briefing books, supplements, annual report files, and responses to Regulatory Agency questions.
• Provides support, as needed, for meetings/teleconferences with US regulatory agencies.
• Interacts with regulatory agencies to answer questions regarding submissions.
• Ensures quality and process improvements within the US and provides cross-portfolio resource support as appropriate.
• Manage compliance within defined portfolio/activity streams in line with our expectations.
• Provides advice on US-specific activities, ways of working, and processes.
• Proactively identify potential risks and manage the impact of regulatory changes within the defined scope of responsibility.
• Develop up-to-date knowledge of regulatory requirements, as well as technical trends.
• Work with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives.

Basic Qualifications:

• Bachelor’s Degree in Pharmaceutical or Life Sciences, Chemistry, Biology, Medicine, or a similar discipline.
• Minimum 8 years of experience in Regulatory Affairs.
• Experience working on FDA applications, OTC monograph products, chemistry, manufacturing, and controls.
• Proficient knowledge of US FDA regulations.
• Excellent communication skills, stakeholder management, and enjoys working in multidisciplinary teams.
• Ability to manage and prioritize projects of high complexity.
• Experience leading end-to-end regulatory processes for new product launches.
• Demonstrated ability to lead projects or cross-functional teams.

Additional Preferred Qualifications:

• Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or a similar discipline.
• Experience at a large global pharmaceutical or OTC CPG company.
• Experience leading global teams.
• Project management experience.
• Experience communicating with FDA (including FDA meetings, briefing books, and responses to Regulatory Agency questions).
• Agile and distributed decision-making – using evidence and applying judgment to balance pace, rigor, and risk.
• Commitment to delivering high-quality results, overcoming challenges, focusing on what matters, and execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills, and share learning both internally and externally.
• Translating strategy into action through a compelling narrative, motivating others, setting objectives, and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.

Applicant Notices & Disclaimers

• For information on benefits, equal opportunity employment, and location-specific applicant notices, click here

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $73.00/hr.