Regulatory Affairs Manager

gsknch; México; On-site; MXN 900,000 - 1,200,000; Full time

Job summary

Haleon seeks an experienced Regulatory Affairs Manager to design and implement regulatory strategies in Mexico, ensuring timely approvals and lifecycle management. You will coordinate with local, regional, and global stakeholders to navigate regulatory requirements and maintain compliant operations.

The role emphasizes leadership, strategic oversight of dossiers, and collaboration with Commercial, Quality, and Supply Chain teams to support product development and market access.

Qualifications

• Bachelor’s degree in a scientific discipline and 5+ years in Regulatory Affairs.
• Experience with global regulatory submissions and lifecycle management.
• Proven ability to influence stakeholders across matrix organizations.

Responsibilities

• Design and implement regulatory strategies to support growth and lifecycle management in Mexico.
• Collaborate with local, regional, and global stakeholders to secure timely approvals.
• Prepare and submit regulatory dossiers to Mexican authorities and respond to inquiries.
• Monitor changes in regulations and ensure ongoing compliance with policies.
• Partner with Commercial, Marketing, Trade Marketing, Supply Chain, Quality, and Sales teams.
• Represent the company in interactions with regulatory authorities and associations.
• Lead, coach, and develop regulatory team members and drive process improvements.
• Maintain regulatory documentation, submissions, and correspondence.

Skills

Regulatory strategy

Stakeholder management

People leadership

Regulatory submissions

English proficiency

Spanish proficiency

Communication

Education

Bachelor's in Pharmacy/ Chemistry/ Medicine

Job description

Welcome to Haleon. We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter - one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands - including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® - lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now it's time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose - to deliver better everyday health with humanity - at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

As Regulatory Affairs Manager , you will be responsible for designing and implementing regulatory strategies that support business growth, innovation, and product lifecycle management in Mexico. You will work closely with local, regional, and global stakeholders to secure timely regulatory approvals, ensure compliance with applicable regulations, and represent the company before regulatory authorities and industry associations.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, including:

• Develop and implement regulatory strategies for product registrations, variations, renewals, and lifecycle management activities in Mexico.
• Ensure timely regulatory approvals that support innovation, line extensions, and business objectives.
• Prepare, review, and submit regulatory dossiers and responses to Mexican Regulatory Authorities.
• Monitor and assess changes in local regulatory requirements, ensuring ongoing compliance with applicable legislation and company policies.
• Partner closely with Commercial, Marketing, Trade Marketing, Supply Chain, Quality, and Sales teams to support product development and commercialization plans.
• Represent the company in interactions, negotiations, and communications with regulatory authorities.
• Conduct regulatory risk assessments and provide strategic recommendations to senior leadership.
• Support manufacturing site inspections and activities related to obtaining required regulatory certifications, where applicable.
• Provide regulatory oversight for clinical and bioequivalence studies, where applicable.
• Review and approve promotional materials requiring regulatory authorization while ensuring compliance with local regulations and corporate policies.
• Drive continuous improvement initiatives to enhance efficiency, productivity, and effectiveness within the regulatory organization.
• Maintain accurate regulatory documentation, submissions, and correspondence.
• Build strong external partnerships with industry associations and regulatory stakeholders to help shape the external regulatory environment.
• Lead, coach, and develop members of the regulatory team, fostering growth and capability building.
• Navigate complex regional and global matrix environments to deliver business results.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in a scientific discipline such as Pharmacy, Chemistry, Medicine, or a related field.
• 5+ years of experience as a Regulatory Affairs Manager.
• Strong experience within global consumer healthcare, pharmaceutical, or related industries.
• Demonstrated knowledge of Mexican regulatory requirements and regulatory submission processes.
• Experience supporting product lifecycle management, registrations, variations, and renewals.
• Excellent verbal and written communication skills in both English and Spanish.
• Experience managing and developing people and teams.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Strong scientific evaluation, interpretation, and communication skills.
• Experience managing broad portfolios including medicines and medical devices.
• Strong project management capabilities.
• Proven ability to influence stakeholders across complex matrix organizations.
• Creative, innovative, and solution-oriented mindset.
• Strong business acumen and results orientation.
• Ability to assess and manage regulatory risks effectively.Experience working directly with regulatory authorities and trade associations.
• Strong interpersonal skills with the ability to build trust and collaborative relationships.
• High sense of urgency, attention to detail, and ability to work independently

Job Posting End Date

2026-11-03

Equal Opportunities

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected - all in support of understanding and best serving the needs of our consume