Assistant Manager Medical Affairs

Why This Role Matters

Medical Affairs professionals play a vital role in connecting scientific knowledge with clinical practice, regulatory compliance, and commercial strategy. They ensure that pharmaceutical products are supported by accurate scientific evidence, regulatory documentation, and meaningful engagement with healthcare professionals.

Job Description

Pharmed Limited is hiring an Assistant Manager – Medical Affairs in Bangalore, Karnataka. This role involves medical writing, regulatory support, clinical research coordination, and collaboration with healthcare professionals and key opinion leaders (KOLs). The position is suitable for professionals with experience in pharmaceutical medical affairs, regulatory submissions, and scientific communication.

Key Features of the Role

• Position: Assistant Manager – Medical Affairs
• Company: Pharmed Limited
• Location: Bangalore, Karnataka, India
• Industry: Pharmaceutical / Medical Affairs
• Employment Type: Full-Time
• Experience Required: 6 Months – 3 Years

Responsibilities

• Support preparation of regulatory dossiers for new product submissions and respond to regulatory authority queries such as CDSCO.
• Prepare and present regulatory submissions to advisory or expert committees when required.
• Develop and maintain FSSAI product dossiers for regulatory and customer inquiries.
• Track regulatory developments and present updates to management.
• Respond to product-related medical queries from healthcare professionals and the marketing team.
• Review and approve medical content used in brand promotional materials and digital marketing.
• Develop monographs, training manuals, and CME slide decks for product launches.
• Review scientific literature and prepare study summaries for management and marketing teams.
• Develop scientific presentations for medical education programs and CMEs.
• Conduct surveys and market research on new product concepts with Key Opinion Leaders (KOLs).
• Coordinate with KOLs and Contract Research Organizations (CROs) for clinical studies and manuscript writing.
• Participate in planning and conducting clinical studies and trials.
• Support pharmacovigilance activities including adverse event reporting, safety monitoring, and PSUR coordination.

Required Qualification

• Postgraduate degree in Pharmacy, Pharmacology, Pharmaceutics, Mac . Pharmacology, Pharm.D, or equivalent.

Important Requirements

• 6 months to 3 years of experience in Medical Affairs, Regulatory Affairs, or Medical Writing within the pharmaceutical industry.
• Experience with CDSCO or FSSAI regulatory submissions is preferred.
• GCP certification or pharmacovigilance training is an advantage.
• Prior experience working with KOLs or CROs is beneficial.

What We Offer

• Opportunity to work in pharmaceutical medical affairs and regulatory functions.
• Exposure to clinical research, regulatory submissions, and medical communication.
• Collaboration with healthcare professionals, KOLs, and research organizations.

Experience and Skills

• Medical and scientific writing
• Medico-marketing communication and content development
• Regulatory dossier preparation (CDSCO, FSSAI)
• Clinical research and trial coordination
• Pharmacovigilance support and adverse event reporting
• Proficiency in MS Office (Word, Excel, PowerPoint)
• Strong analytical thinking and scientific literature interpretation
• Excellent written and verbal communication skills

Company Overview

Pharmed Limited is a pharmaceutical organization involved in developing and supporting healthcare products through scientific research, regulatory compliance, and medical affairs initiatives. The company works closely with healthcare professionals and regulatory bodies to ensure product quality, safety, and effective communication of medical information.

FAQs

1. What qualification is required for this role?
   Candidates must have a postgraduate degree in Pharmacy, Pharmacology, Pharmaceutics, Pharm.D, or a related field.

2. How much experience is required?
   The role requires 6 months to 3 years of experience in medical affairs, regulatory affairs, or medical writing.

3. Where is the job located?
   The position is based in Bangalore, Karnataka, India.

4. Does the role involve travel?
   Yes, occasional travel may be required for meetings with KOLs, CRO coordination, and scientific conferences.

Application Tips

• Highlight postgraduate qualifications in pharmacy or pharmacology.
• Mention experience in regulatory submissions, medical writing, or clinical research.
• Showcase knowledge of CDSCO and FSSAI regulations.
• Emphasize skills in scientific communication and literature review.