Senior Manager Regulatory Affairs

Senior Manager Regulatory Affairs at Xcede Senior Manager Regulatory Affairs at Xcede in Lyons, New Jersey Posted in 2 days ago.

Type:

full-time

Job Description:

Job Purpose:

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

Key Responsibilities:

• 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 labelling and artwork review and 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 agency
• Interacts with regulatory agencies to answer questions regarding submissions.
• Ensures quality and process improvements within US and provides cross portfolio resources support as appropriate
• Manage compliance within defined portfolio/activity streams in line with Haleon expectations
• Provides advice on US-specific activities and ways of working and processes;
• Proactively identify potential risks and manage impact of regulatory changes within defined scope of responsibility
• Develop up-to-date knowledge of regulatory requirements, as well as technical trends Regulatory Affairs Senior Manager
• Work with regulatory colleagues and other stakeholders to proactively look for opport unities and solutions to challenges, including leading implementation of improvement initiatives

Basic Qualifications:

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

Additional Preferred Qualifications:

• Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or 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 judgement to balance pace, rigor and risk
• Commitment to delivering high quality results, overcoming challenges, focusing on what matters, 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 - a compelling narrative, motivating others, setting objectives and delegation
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally