Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.
We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. 
For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).
‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable.  Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency
Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour, religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Head of Regulatory Affairs (RA) will drive strategic planning and execution for regulatory operations in Thailand, ensuring alignment with business objectives. This role involves liaising with FDA officials, overseeing review and submission of registrations, responding to deficiencies, and providing crucial regulatory guidance to internal teams. Responsibilities also include providing post-approval changes, safety, labelling and annual updates to the FDA within the required timelines and format. Ensuring timely filing and approvals of all regulatory documentation is essential for maintaining operational efficiency.

Roles & Responsibilities

Regulatory Strategy & Compliance

• Develop and implement regulatory strategies to ensure compliance with Thai FDA and international standards.
• Monitor regulatory changes and provide strategic guidance to internal teams.
• Ensure timely submission and approval of product registrations, variations, and renewals.

Government & Stakeholder Engagement

• Act as the primary liaison with Thai FDA, Ministry of Public Health, and other regulatory bodies.
• Represent the company in industry forums and regulatory discussions.
• Advocate for favourable regulatory policies and industry best practices.

Product Registration & Lifecycle Management

• Oversee the preparation and submission of regulatory dossiers for new and existing products.
• Ensure compliance with GMP, GCP, and GLP standards.
• Manage post-approval regulatory activities, including labelling updates and safety reporting.

Cross-functional Collaboration

• Work closely with R&D, Quality Assurance, Legal, and Commercial teams to align regulatory strategies with business objectives.
• Provide regulatory insights for product development and market expansion.

Risk Management & Compliance Oversight

• Identify regulatory risks and develop mitigation strategies.
• Ensure adherence to local and global regulatory requirements.
• Conduct internal audits and training sessions on regulatory compliance.

Qualifications, Experience, Skills & Attributes

Educational qualification: A Bachelor or Master degree in Pharmacy

Minimum work experience: 15 years’ experience in Thai pharmaceutical industry

Skills & attributes:

• Strong knowledge of Thai FDA regulations, ASEAN regulatory frameworks, and international compliance standards
• Proven leadership experience in managing regulatory teams and government relations.
• Excellent communication (English and Thai) and negotiation skills.
• Expertise in drug registration, clinical trial approvals, and pharmacovigilance.
• Established network and experience with regulatory authorities.
• Ability to navigate complex regulatory environments and influence policy decisions
• Strong analytical and problem-solving skills