Regulatory Affairs Specialist, Vision Care

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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The Regulatory Affairs Specialist is responsible for all aspects of regulatory responsibilities in Thailand Myanmar Australia and New Zealand. This role blends regulatory strategy with hands-on submission management labeling compliance post-market surveillance and cross-functional collaboration to ensure timely market access and ongoing conformity with local requirements. Additionally this role is responsible for directing post-marketing Lifecycle Management (LCM) Regulatory activities (e.g. claims change management re-registrations copy clearance global LCM labeling support and external environment surveillance).

Responsibilities

• Directs both growth/innovation and post-marketing Lifecycle Management (LCM) Regulatory activities (e.g. claims change management renewals copy clearance global LCM labeling support and external environment surveillance). Oversees the creation of global regulatory product development strategies and preparation/submission of marketing approval applications to health authorities to ensure that development plans meet global regulatory requirements. Ensure compliance with product post-marketing approval requirements. Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture.

• Interacts with internal health authorities and global regulatory personnel to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business

• Assess the acceptability of documentation for submission filing to comply with regulatory requirements for clinical trials marketing applications and corporate goals to secure submission approval. Identify and implement new regulatory policies processes and SOPs as appropriate.

• Participate in new product development teams to provide input and expertise on regulatory requirements determination of global regulatory strategies review and approval of documentation to support regulatory submissions worldwide.

• Monitor and assess impact of changing regulations on submission strategies.

• Provides strategic direction and advice regarding regulatory pathways and timelines.

• Evaluate proposed preclinical clinical and manufacturing changes for regulatory filing strategies.

• Provide medical review and assure compliance of promotional materials in accordance with approved labelling application regulations and industry standards

• Participate in local industry/trade association meetings

• Performs additional duties as assigned.

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