TCS is seeking a Senior Regulatory Affairs Specialist to support regional regulatory strategies, submissions, product registrations, and lifecycle management activities across regulated markets. This role partners with integral and regional stakeholders to ensure compliance with applicable health authority requirements and supports the successful development, registration, and maintenance of pharmaceutical products.

The Senior Regulatory Affairs Specialist will collaborate with Global Regulatory Affairs teams, local affiliates, and cross-functional partners to prepare and manage regulatory submissions, support health authority interactions, maintain product registrations, and contribute to continuous improvement initiatives within the regulatory function

Key Responsibilities

- Support the implementation and execution of regional regulatory strategies.
- Lead regional regulatory planning and submission activities.
- Collaborate with Global Regulatory Affairs teams, regional teams, and local operating companies.
- Coordinate regulatory submissions and product lifecycle management activities.
- Prepare, review, and support submission dossiers for Health Authorities.
- Manage country-specific regulatory requirements and submission timelines.
- Support responses to Health Authority questions and regulatory interactions.
- Participate in labeling strategy discussions and implementation activities.
- Drive stakeholder communication and cross-functional alignment.
- Contribute to process improvement, knowledge management, and regulatory excellence initiatives.




- Support regulatory activities in accordance with applicable regional regulations and international guidelines.
- Monitor regulatory developments and communicate potential impacts to stakeholders.

Skills & Qualifications

Required

- Bachelor's degree in Pharmacy, Life Sciences, Health Sciences, or a related discipline.
- Minimum 8 years of relevant experience, including significant experience in Regulatory Affairs.
- Experience supporting drug development and product lifecycle management activities.
- Knowledge of global regulatory requirements, submission processes, and registration activities.
- Excellent verbal and written communication skills in English.

Preferred

- Experience working with global or regional regulatory teams.
- Exposure to interactions with Health Authorities and regulatory agencies.
- Experience supporting regulatory documentation, labeling activities, and submission planning.

Location

Mexico City, Queretaro, Guadalajara or Monterrey

Work Model

Hybrid

Benefits

- Major Medical Insurance.
- Dental Insurance.
- Life Insurance.
- Grocery Vouchers.
- Christmas Bonus.
- Vacation days according to Mexican labor law.
- Profit Sharing (PTU).

Other Considerations

Tata Consultancy Services is an equal opportunity employer. Our commitment to diversity and inclusion drives us to provide equal opportunities to all candidates who meet our required knowledge and competency needs—regardless of socio-economic background, race, color, national origin, religion, sex, gender identity, age, marital status, disability, sexual orientation, or any other characteristic.

📌 Senior Regulatory Affairs Specialist (Ciudad de México)
🏢 Tata Consultancy Services
📍 Ciudad de México