Genedrift Hiring 2026: Senior Executive – Regulatory Affairs | Remote Job in India

Genedrift is hiring for the position of Senior Executive – Regulatory Affairs (JP6 – DIN11) in India. This is an excellent opportunity for pharmaceutical professionals with 2–5 years of experience in Regulatory Affairs, CMC documentation, dossier preparation, and regulatory submissions for emerging markets.

The selected candidate will work with internal and external teams to review technical documentation, support health authority (HA) submissions, perform gap analysis, and ensure regulatory compliance across various markets.

Job Details

Key Responsibilities

• Perform CMC reviews of CTD and ACTD dossiers, technical documentation, Medical Data Packages, SmPCs, PIs, PILs, and labelling documents.
• Prepare and review regulatory dossiers for submissions across emerging markets.
• Conduct adequacy reviews and gap analyses of CTD, ACTD, and non-CTD documentation.
• Attend pre-submission meetings with health authorities and prepare meeting minutes and related documentation.
• Review and compile dossiers while coordinating with internal teams and clients to close comments.
• Evaluate deficiencies, shortcomings, and supplementary information requests received from health authorities.
• Support regulatory submissions, document translations, and pre- and post-submission activities.
• Maintain accurate records in accordance with internal and client SOPs and data security requirements.
• Prepare customized reports and provide regulatory intelligence and market-specific regulatory insights.
• Collaborate with stakeholders to ensure quality deliverables, timely submissions, and client satisfaction.

Candidate Profile and Eligibility

Candidates should have the following qualifications and skills:

• B.Pharm or M.Pharm degree.
• 2–5 years of relevant experience in Regulatory Affairs.
• Experience with biologics, biosimilars, injectables, vaccines, or medical devices is relevant to the advertised opportunity.
• Knowledge of CTD/ACTD dossiers, CMC documentation, and health authority submissions.
• Understanding of emerging-market regulations and regulatory guidelines.
• Strong project management, analytical, and problem-solving skills.
• Excellent written and verbal communication and presentation skills.
• Proficiency in computer applications and online office tools.
• Ability to work under pressure, adapt to changing priorities, and deliver quality work within tight deadlines.

Why Consider This Opportunity?

This remote opportunity offers Regulatory Affairs professionals the chance to work on technical documentation, dossier reviews, and regulatory submissions for emerging markets while collaborating with cross-functional teams and clients.

How to Apply for Genedrift Careers

Interested and eligible candidates can apply online through the link below.

Apply Here:

Candidates are encouraged to review the official job requirements and ensure their experience aligns with the role before submitting an application.

Frequently Asked Questions (FAQs)

1. What is the qualification required for the Genedrift Regulatory Affairs job?

Candidates with B.Pharm or M.Pharm qualifications are eligible to apply.

2. How much experience is required?

The advertised experience requirement is 2–5 years.

3. Is this a remote job?

Yes, the position is advertised as a remote opportunity in India.

4. What is the job profile?

The role involves CMC documentation review, CTD/ACTD dossier preparation, gap analysis, regulatory submissions, health authority coordination, and compliance documentation.

5. What is the job code?

The job code is JP6 – Senior Executive – Regulatory Affairs (DIN11).