Senior Manager, Regulatory Affairs, OTC (CMC)

Job Title: Senior Manager, Regulatory Affairs, OTCDuration: 6 Months (possible extension or conversion into FTE)Location: Warren, NJ 7059 (Hybrid- 3 days)Shift: 8am-5PMJob PurposeThe 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 ResponsibilitiesThese 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 & DisclaimersFor information on benefits, equal opportunity employment, and location-specific applicant notices, click hereAt 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.