Senior Regulatory Affairs Lead – Regional Submissions

Tata Consultancy Services Limited

Ciudad de México

Hybrid

MXN 800,000 - 1,200,000

Full time

5 days ago

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Benefits offered by this job

Major Medical Insurance

Life Insurance

Grocery Vouchers

Christmas Bonus

Vacation days according to Mexican lab

Profit Sharing (PTU)

Job summary

Tata Consultancy Services Limited is seeking a Senior Regulatory Affairs Specialist to drive regional regulatory strategies, submissions, and lifecycle management for pharmaceutical products across markets. The role collaborates with Global Regulatory Affairs teams, local affiliates, and cross-functional partners to ensure compliance.

The ideal candidate will have 8+ years in Regulatory Affairs, experience with drug development, and strong English communication.

Qualifications

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.

Responsibilities

Support regional regulatory strategies and submissions.
Lead regional regulatory planning and submission activities.
Coordinate regulatory submissions and product lifecycle management activities.
Prepare, review, and support submission dossiers for Health Authorities.
Monitor regulatory developments and communicate potential impacts to stakeholders.
Drive stakeholder communication and cross-functional alignment.