Sr. Associate, Promotional Regulatory Affairs Specialist, ASIA (Japanese Speaker)

At Alcon, we are inspired by the meaningful work we do to help people see brilliantly. As the global leader in eye care, we boldly innovate, champion progress, and act with speed. We recognize and celebrate the contributions of our people, offering career opportunities that empower growth and fulfillment. Together, we go above and beyond to make a lasting impact on the lives of our patients and customers. We cultivate an inclusive culture and invite diverse, talented individuals to join us in shaping the future of eye care.

Sr. Associate, Promotion/Advertising Regulatory Affairs (Life Sciences) is responsible for ensuring compliance of promotional and advertising materials with applicable global, regional, and local regulatory requirements. The role serves as a key regulatory partner to commercial, marketing, and cross-functional teams by providing regulatory guidance, reviewing promotional content, and supporting compliance initiatives that protect both patients and the organization.

The position supports the development, implementation, and maintenance of regulatory compliance programs related to product promotion and advertising activities. It collaborates closely with Marketing, Medical Affairs, Legal, Quality, Research & Development, and Regulatory Affairs teams to ensure that promotional communications remain compliant with applicable regulations, industry standards, and company policies.

Additionally, the Sr. Associate is responsible for maintaining compliance with applicable SOPs, GxP requirements, company policies, internal controls, and quality standards while contributing to continuous improvement initiatives and fostering a strong culture of regulatory compliance.

• Review, evaluate, and approve promotional and advertising materials to ensure compliance with applicable regulatory requirements, company policies, and industry standards.
• Provide regulatory guidance to commercial, marketing, and cross-functional teams throughout the development and review of promotional campaigns and materials.
• Interpret regulations, guidance documents, and industry codes related to promotional and advertising activities.
• Conduct independent research and regulatory assessments to support compliance decisions and promotional review activities.
• Partner with Marketing, Medical Affairs, Legal, and Quality functions to facilitate compliant communication strategies.
• Support regulatory review processes for digital, print, social media, sales training, and external communication materials.
• Monitor changes in regulatory requirements, industry codes, and enforcement trends and communicate impacts to stakeholders.
• Provide regulatory input on new product opportunities, product claims, and marketing initiatives arising from regulatory changes.
• Support regulatory reporting and documentation requirements associated with promotional and advertising compliance.
• Contribute to process improvement initiatives that enhance regulatory review efficiency and compliance effectiveness.

• Perform detailed compliance reviews of promotional materials, product claims, labeling references, and advertising content.
• Investigate compliance-related concerns, inquiries, deviations, complaints, or issues raised by internal stakeholders, customers, or regulatory agencies.
• Evaluate proposed marketing claims and supporting evidence to ensure alignment with approved indications, regulations, and scientific data.
• Maintain complete, accurate, and auditable records of regulatory reviews, approvals, and compliance decisions.
• Support preparation and management of documentation related to audits, inspections, and compliance assessments.
• Collaborate with stakeholders to address review comments, identify compliance risks, and implement appropriate corrective actions.
• Participate in promotional review committee meetings and cross-functional discussions as required.
• Track regulatory commitments and ensure timely completion of assigned deliverables.
• Support implementation of regulatory process enhancements and best practices.
• Exercise sound judgment in evaluating regulatory risks and escalating issues when appropriate.

• Ensure all promotional and advertising activities comply with applicable global, regional, and local regulations.
• Develop, implement, and maintain policies, procedures, and controls supporting promotional compliance requirements.
• Support internal audits, compliance assessments, and regulatory inspections.
• Conduct reviews and evaluations of existing policies, procedures, and documentation to identify compliance gaps and improvement opportunities.
• Develop and deliver compliance awareness initiatives, educational materials, and training programs to promote regulatory compliance across the organization.
• Maintain compliance with GxP regulations by adhering to approved Standard Operating Procedures (SOPs), documentation requirements, and quality standards.
• Ensure accurate, complete, and auditable compliance documentation is maintained in accordance with company and regulatory requirements.
• Complete all mandatory compliance, quality, and regulatory training within established timelines.
• Support corrective and preventive action activities arising from audits, inspections, or compliance investigations.
• Promote a culture of integrity, accountability, and continuous compliance improvement.

• Actively support organizational values and ways of working by demonstrating collaboration, accountability, inclusiveness, and continuous improvement.
• Build and maintain effective working relationships with internal and external stakeholders.
• Share regulatory knowledge, best practices, and compliance insights with colleagues and business partners.
• Support cross-functional project teams and contribute to successful project execution.
• Mentor and provide guidance to less experienced team members when appropriate.
• Foster strong collaboration across Regulatory Affairs, Marketing, Medical Affairs, Quality, Legal, and Research & Development functions.
• Contribute to a high-performing team environment focused on quality, compliance, and business excellence.

(minimum/desirable)

• Bachelor's Degree in Life Sciences, Pharmacy, Regulatory Affairs, Biomedical Sciences, Chemistry, Biotechnology, or a related scientific discipline.
• Advanced degree or professional certification in Regulatory Affairs is an added advantage.

• Fluent in written and spoken English and Japanese
• Additional language capabilities are an advantage depending on regional responsibilities and stakeholder requirements.

• 3 to 5 years of relevant experience in Regulatory Affairs, Promotional Review, Advertising & Promotion Compliance, Quality Compliance, Medical Devices, Pharmaceuticals, Biotechnology, or related regulated industries.
• Experience reviewing promotional, advertising, digital, or marketing materials within a regulated environment.
• Strong knowledge of global and local regulatory requirements governing product promotion and advertising.
• Experience working with cross-functional stakeholders including Marketing, Medical Affairs, Legal, Quality, and R&D teams.
• Demonstrated experience supporting audits, inspections, compliance activities, and regulatory documentation.
• Experience within the medical device, healthcare, ophthalmology, pharmaceutical, or life sciences industry is preferred.
• Knowledge of GxP requirements and quality management systems is preferred.

• Strong understanding of promotional and advertising regulations and compliance requirements.
• Regulatory review and approval process management.
• Policy and procedure development and implementation.
• Compliance investigation and issue resolution.
• Risk assessment and regulatory interpretation.
• Document management and regulatory record keeping.
• Excellent analytical, problem-solving, and decision-making skills.
• Proficiency with Microsoft Office applications and regulatory documentation systems.

• Strong attention to detail and commitment to quality and compliance.
• Excellent analytical and critical thinking abilities.
• Strong written and verbal communication skills.
• Effective stakeholder engagement and influencing skills.
• Ability to manage multiple priorities in a fast-paced and highly regulated environment.
• Strong organizational and project management capabilities.
• Proactive, adaptable, and solutions-oriented mindset.
• Ability to work independently while collaborating effectively within cross-functional and global teams.

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