DRA Manager Job Opening at Florencia Healthcare

Florencia Healthcare invites applications from qualified and experienced professionals for the position of DRA Manager (Drug Regulatory Affairs). This opportunity is ideal for candidates seeking career growth in pharmaceutical regulatory affairs and compliance management.

Position Details

Job Title: DRA Manager (Drug Regulatory Affairs)

Industry: Pharmaceutical

Company: Florencia Healthcare

Experience Required: Minimum 5 Years

Educational Qualification: B.Pharm / M.Pharm

Job Type: Full-Time

Key Responsibilities

The selected candidate will be responsible for:

• Preparation, review, and submission of regulatory dossiers.
• Coordination with regulatory authorities for approvals and compliance requirements.
• Compilation and maintenance of CTD, ACTD, and country-specific regulatory documents.
• Lifecycle management activities including variations, renewals, and amendments.
• Review of product labeling, packaging materials, and regulatory documentation.
• Monitoring changes in national and international regulatory guidelines.
• Ensuring regulatory compliance throughout the product lifecycle.
• Supporting product registration activities for domestic and export markets.

Required Skills

• Strong knowledge of pharmaceutical regulatory affairs.
• Experience in dossier preparation and submissions.
• Understanding of CTD/eCTD documentation.
• Knowledge of global regulatory requirements.
• Excellent documentation and communication skills.
• Ability to manage multiple projects and timelines.

Eligibility Criteria

Candidates applying for this position should possess:

• B.Pharm or M.Pharm degree from a recognized institution.
• Minimum 5 years of experience in Regulatory Affairs.
• Good understanding of pharmaceutical registration processes.
• Strong analytical and problem-solving abilities.

Why Join Florencia Healthcare?

• Opportunity to work with a growing pharmaceutical organization.
• Exposure to domestic and international regulatory projects.
• Professional growth and career advancement opportunities.
• Dynamic and collaborative work environment.

How to Apply

Interested candidates can share their updated resume through the following contact details:

Email: hrd@florenciahealthcare.com

Alternate Email: hr.florenciahealthcare@gmail.com

Contact Number: +91-8810226562

Alternate Contact Number: +91-9968996869

Website: www.florenciahealthcare.com

Important Note

Candidates are advised to verify all employment-related details directly with the employer before applying. Selection and interview processes are solely managed by Florencia Healthcare.