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Drug Regulatory Affairs Openings at Evolet Healthcare

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Drug Regulatory Affairs Openings at Evolet Healthcare in Gurugram for CTD ACTD submissions global regulatory experience apply online now


About the Company

Evolet Healthcare Pvt. Ltd. is a fast-growing pharmaceutical organization with a strong presence in global regulatory markets. The company is actively involved in the development, registration, and commercialization of pharmaceutical products across regulated and semi-regulated regions including CIS, ASEAN, LATAM, and African countries. Drug Regulatory Affairs Openings

Evolet Healthcare is recognized for its structured regulatory processes, compliance-driven approach, and focus on international market expansion. The organization follows global regulatory standards such as ICH guidelines and GMP practices, providing regulatory professionals an opportunity to work on complex, multi-country submissions and product life cycle activities.

As part of its continued growth, Evolet Healthcare is expanding its Drug Regulatory Affairs team and inviting experienced professionals to join its Gurugram office. Drug Regulatory Affairs Openings


Job Details

Job Title:
Drug Regulatory Affairs (DRA) Executive / Senior Executive

Department:
Drug Regulatory Affairs

Job Type:
Full-Time, Onsite

Location:
Gurugram, Haryana

Experience Required:
2 to 6 years

Industry:
Pharmaceuticals / Regulatory Affairs

Application Mode:
Online Application

Job Status:
Verified Job


Job Description

Evolet Healthcare is looking for skilled Drug Regulatory Affairs professionals who can manage end-to-end regulatory activities for global markets. This role is suitable for candidates with strong hands-on experience in CTD and ACTD dossier preparation, regulatory submissions, and life cycle management activities. Drug Regulatory Affairs Openings

The selected candidates will be responsible for coordinating with internal stakeholders, manufacturing units, and regulatory authorities to ensure timely submissions and approvals. The role involves handling regulatory queries, ensuring compliance with international guidelines, and supporting the companyโ€™s expansion in multiple global regions.

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This position offers excellent exposure to international regulatory frameworks, real-time Ministry of Health interactions, and long-term career growth in pharmaceutical regulatory affairs. Drug Regulatory Affairs Openings


Key Responsibilities

  • Handle routine Drug Regulatory Affairs activities independently
  • Prepare, compile, and submit CTD and ACTD dossiers for fresh registrations and re-registrations
  • Manage Product Life Cycle Management (PLCM) activities including variations and renewals
  • Respond to queries raised by Ministry of Health (MOH) authorities within defined timelines
  • Coordinate with internal departments such as QA, QC, Production, and R&D
  • Liaise with partner manufacturing plants for regulatory documentation and compliance
  • Oversee the complete registration process from dossier initiation to final approval
  • Ensure compliance with ICH guidelines, GMP standards, and country-specific regulations
  • Handle region-specific regulatory requirements for CIS, ASEAN, LATAM, and African markets
  • Maintain accurate regulatory documentation and submission trackers
  • Support internal and external audits related to regulatory submissions
  • Provide regulatory guidance and training to team members when required
  • Travel to manufacturing sites for regulatory coordination, as necessary

Drug Regulatory Affairs Openings


Skills and Qualifications

Educational Qualifications

  • Bachelor of Pharmacy (B.Pharm) โ€“ Any specialization
  • Master of Pharmacy (M.Pharm) โ€“ Any specialization

Experience

  • Minimum 2 years and up to 6 years of experience in Drug Regulatory Affairs
  • Proven experience in handling CTD and ACTD dossiers for international markets

Mandatory Regulatory Knowledge

  • Strong understanding of ICH guidelines
  • Practical exposure to global regulatory submission processes
  • Knowledge of GMP practices and regulatory compliance

Desired Skills

  • Strong analytical and documentation skills
  • Ability to interpret regulatory guidelines and technical data logically
  • Experience handling multiple submissions simultaneously
  • Proficiency in MS Word, Excel, email, and internet-based regulatory tools
  • Excellent English communication skills, both written and verbal
  • Proactive, systematic, and detail-oriented working approach
  • Ability to work independently as well as in cross-functional teams
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Drug Regulatory Affairs Openings


Benefits and Perks

  • Competitive salary package aligned with industry standards
  • Provident Fund (PF) benefits
  • Medical Health Insurance coverage
  • Rewards and recognition programs for performance
  • Professional and supportive work environment
  • Exposure to global regulatory markets and authorities
  • Continuous learning and skill development opportunities
  • Long-term career growth in regulatory affairs

Drug Regulatory Affairs Openings


Salary and Compensation

Estimated CTC Range:
โ‚น6,00,000 โ€“ โ‚น10,00,000 per annum

The final compensation will depend on the candidateโ€™s experience, regulatory exposure, and performance during the interview process.


Why You Should Join Evolet Healthcare

Evolet Healthcare offers a strong platform for regulatory professionals who want to build a long-term career in global Drug Regulatory Affairs. The organization provides exposure to multi-country submissions, diverse regulatory frameworks, and real-time interactions with international regulatory authorities. Drug Regulatory Affairs Openings

Employees benefit from a structured regulatory environment, access to continuous learning, and opportunities to work on complex dossiers across multiple regions. With its expanding global footprint, Evolet Healthcare ensures stability, professional growth, and meaningful contributions to international pharmaceutical markets.

Working at the Gurugram location also provides access to one of Indiaโ€™s major pharmaceutical and corporate hubs, offering excellent professional networking and career advancement opportunities. Drug Regulatory Affairs Openings


FAQs

Q1: Who is eligible to apply for this position?
Candidates with 2 to 6 years of experience in Drug Regulatory Affairs and CTD/ACTD dossier preparation are eligible.

Q2: Is experience in global markets mandatory?
Yes, experience with international regulatory submissions, especially CIS, ASEAN, LATAM, or African markets, is highly preferred.

Q3: What qualifications are required for this role?
B.Pharm or M.Pharm candidates from any specialization can apply.

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Q4: Is this a work-from-home role?
No, this is a full-time onsite position based in Gurugram.

Q5: Does the role involve travel?
Yes, occasional travel to manufacturing sites may be required for regulatory coordination.


How to Apply

Apply Here

For verified pharma job updates, visit PharmaJobHub.in โ€“ Indiaโ€™s trusted pharma career portal.

Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.

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