Senior Manager, Regulatory Affairs - OTC
Senior Manager, Regulatory Affairs - OTC
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Job Description
Hello. Were Haleon. A new world-leading consumer health company. Shaped by all who join us. Together were improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands including Sensodyne Panadol Advil Voltaren Theraflu Otrivin and Centrum through a unique combination of deep human understanding and trusted science. Whats more were achieving it in a company that were in control an environment that were co-creating. And a culture thats uniquely ours. Care to join us. It isnt a question.
With category leading brands such as Sensodyne Voltaren and Centrum built on trusted science and human understanding and combined with our passion knowledge and expertise were uniquely placed to do this and to grow a strong successful business.
This is an exciting time to join us and help shape the future. Its an opportunity to be part of something special.
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 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 organizational skills with out-of-the-box thinking is a must.
Why you
Basic Qualifications:
Bachelors 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
Location: This role is hybrid based in Warren NJ with in-office requirements of 3 times per week.
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: $146087 to $200869 plus a 18% bonus.
#Li-Hybrid
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 Haleons compliance to all federal and state US Transparency requirements.
Accommodation Requests
If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process please contact us by sending an email to Please include the following in your email:
Use subject line: Haleon Careers: Job Accommodation Request
Your Name and contact information
Requisition ID and Job Title you are interested in
Location of Requisition (city/state or province/country)
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.
Required Experience:
Senior Manager
Employment Type
Full-Time
