Senior Regulatory Affairs Executive

Job description

Hello job seekers,

We are looking for Senior Regulatory Affairs Executive for Ahmedabad location.

Role Overview

We are looking for a Senior Regulatory Affairs Executive (Senior RA – eCTD and CTD) to lead our regulatory team and manage global submissions, compliance, and product registrations. The role involves dossier compilation (eCTD & CTD), regulatory strategy, and cross-functional collaboration to ensure timely product approvals across international markets.

Key Responsibilities

Prepare, review, and submit dossiers in CTD, ACTD, and eCTD formats.

Develop regulatory strategies for ROW, LATAM, SEA, Africa, and Pacific regions.

Coordinate with CROs to ensure compliance with bioequivalence study requirements.

Manage product lifecycle activities including renewals, variations, and post-marketing compliance.

Liaise with regulatory authorities for product registration and approvals.

Review technical files to ensure compliance with WHO-GMP, ICH, and other global guidelines.

Maintain up-to-date regulatory documentation and submit periodic reports to management.

Mentor and guide junior staff, while driving process improvements in regulatory operations.

What Makes You a Fit

Education

Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.

Experience & Skills

Minimum 6 years of experience in Regulatory Affairs within the pharmaceutical industry.

Strong expertise in dossier compilation (CTD, ACTD, eCTD).

Hands-on experience in bioequivalence studies & regulatory submissions.

Experience with parenteral dossiers is an added advantage.

Excellent communication, leadership, and problem-solving skills.

Proficiency in MS Office (Word, Excel, PowerPoint).

Why Join Us

Leadership Opportunity in shaping global regulatory strategy.

Career Growth in a dynamic and expanding pharmaceutical company.

Competitive Compensation reflecting your expertise and contribution.

Collaborative Culture with cross-functional exposure.

Work-Life Balance with structured processes and compliance focus.

📍 Location: Ahmedabad, Gujarat, India

Interested candidates can share their cv on reshail.paulwhiteforce@gmail.com