Senior Manager, Regulatory Affairs - OTC

About the role

This Senior Manager, Regulatory Affairs - OTC has responsibility for end-to-end regulatory activities for the OTC portfolio, which is comprised primarily of OTC drugs under the Monograph and New Drug Applications. Involves execution of well-constructed regulatory strategies that keep pace with the dynamic regulatory environment. Builds strong relationships with all stakeholders, internal and external. Provides leadership to cross-functional teams, such as product development, medical, legal and marketing, as well as in regulatory.

Role 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.
• Manage compliance within defined portfolio/activity streams in line with Haleon expectations
• Provides advice on US-specific activities and ways of working, processes as mentor or coach; provides support, as needed, for meetings/teleconferences with US regulatory agency
• Prepares registration files, briefing books, supplements, annual report files, and responses to Regulatory Agency questions
• Interacts with regulatory agencies to answer questions regarding submissions.
• Develops and applies the knowledge of current labeling requirements to the creation, review and approval of product labels
• Participates in the review of promotional materials
• Ensures quality and process improvements within US and provides cross portfolio resources support as appropriate
• 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
• Work with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives
• Provide development, coaching and mentorship to the regulatory team

External Engagement

• Monitor regulatory trends that could impact the portfolio, identify & report impact of business
• Active participant externally in industry association activities, ensuring that Haleon POV is considered.

Other Responsibilities

Business Expertise

• Proven knowledge of the competitive and regulatory landscape for OTC Drugs, and how to apply that knowledge when assessing new product opportunities.

Problem Solving

• This role will independently sit on project teams. The regulatory environment for OTC drugs is complex and dynamic. This role must be able to navigate ambiguous regulatory scenarios and be able to provide balanced advice in a manner that can be acted on by commercial teams. Must know how to leverage and interpret regulatory precedent, and other external information to Agency regulations.

Nature & Area of Impact

• 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.

Why you?

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

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

Please save a copy of the job description, as this may be helpful to refer to once the advert closes.

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering. The salary range for this role is: $146,087 to $200,869 plus a 18% bonus.

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At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

Accommodation Requests

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• Use subject line: ‘Haleon Careers: Job Accommodation Request’
• Your Name and contact information
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• Description of specific accommodation you are requesting
• Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted.

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.