Executive / Sr. Executive Regulatory Affairs

Mega Lifesciences; Thane; Vor Ort; INR 800.000 - 1.400.000; Vollzeit

Zusammenfassung

Mega Lifesciences is seeking an Executive / Senior Executive - Regulatory Affairs to work with the Head of Regulatory Affairs in a fast-paced environment, expanding regulatory expertise and supporting successful global product launches.

The role involves managing dossiers, coordinating with vendors, reviewing labeling and artwork, tracking submissions, and aiding post-approval activities to ensure on-time registrations and launches.

Qualifikationen

• Graduate degree in Pharmacy (B.Pharm).
• Minimum 3 years of regulatory experience with new submissions, variations, and renewals in ASEAN, African, CIS, or LATAM markets.
• Strong multitasking ability and ability to handle multiple projects within tight timelines.

Aufgaben

• Prepare, submit, renew, and vary regulatory dossiers per country requirements.
• Coordinate with suppliers, manufacturers and internal teams to obtain documents and resolve queries.
• Review packaging artworks and product documentation for regulatory compliance.
• Track submissions and maintain dossier records for visibility and reporting.
• Support post-approval activities, sample coordination and cross-functional execution to ensure launches.

Kenntnisse

Multitasking

Analytical skills

Attention to detail

Problem solving

Communication

Deadline driven

Ausbildung

B.Pharm

Tools

Excel

PowerPoint

Jobbeschreibung

Are you highly independent person?

Do you hate distractions?

Do you actively seek out problems to solve?

Mega Lifesciences is looking for an Executive / Sr. Executive - Regulatory Affairs (RA) to work closely with the Head - Regulatory Affairsin a fast-paced environment that offers opportunities to expand your regulatory expertise and contribute to successful global product launches.

Job Summary

As an Executive, your key tasks include:

• Managing preparation, submission, renewal, and variation of regulatory dossiers as per country-specific requirements.
• Coordinating with suppliers, manufacturers, and internal stakeholders to obtain regulatory documents, resolve audit gaps, and address health authority queries.
• Reviewing and approving packaging artworks and product-related documentation in compliance with regional regulatory guidelines.
• Tracking regulatory submissions, maintain accurate dossier records, and update status trackers for timely project visibility and reporting.
• Supporting post-approval activities, sample coordination, and cross-functional execution to ensure smooth product registration and launch timelines.

Qualification & Experience

Applications are invited from candidates who meet the following criteria:

• Graduate degree in Pharmacy (B.Pharm)
• Minimum 3 years of regulatory experience with proven exposure to new submissions, variations, and renewals in ASEAN, African, CIS, or LATAM markets.
• Must have strong multitasking ability and a track record of handling multiple projects within tight timelines.

Skills & Knowledge

The ideal candidate is driven, focused, and a problem solver, with:

• Strong analytical and interpretation skills, attention to detail, and proactive problem-solving ability.
• Knowledge of ICH guidelines and regulatory processes for ASEAN, African, CIS, and LATAM regions.
• Proficiency in Excel and PowerPoint for reporting and presentation tasks.
• Ability to coordinate effectively, prioritize competing demands, and work collaboratively in a deadline-driven environment.

For further information, please call +91 22 - 4141 7900 ext. 965.