Medical Affairs Director India & South Asia

MISSION STATEMENT

Despite significant focus and effort, millions of patients in emerging markets still lack access to life-saving medicines. These regions are often deprived of innovative therapies developed in the United States and the European Union, with children especially vulnerable to the lack of timely intervention. Barriers such as funding constraints, regulatory hurdles, and supply chain challenges frequently prevent these critical medications from reaching those who need them most.

Medical Affairs Director

individual contributor

Regional Managing Director for India and South Asia.

FARMAMONDO AND JOB PURPOSE

FarmaMondo is a fast-growing, Swiss-based pharmaceutical group specializing in market access services and full commercialization of specialty medicines through a unique geographical footprint. Our mission is to provide healthcare professionals and patients access to both licensed and unlicensed medicines in emerging markets.

India & South Asia

The primary focus remains Medical Affairs, with oversight and coordination of RA, QA, and PV functions to ensure regulatory compliance and operational excellence. The position will be based in Mumbai.

KEY ACCOUNTABILITIES

Stakeholder Engagement & KOL Management

• Develop and maintain strong relationships with healthcare professionals (HCPs), KOLs, and key decision-makers in hospitals and healthcare institutions.
• Act as the primary scientific point of contact for external stakeholders in the region.
• Support the execution of local medical activities such as advisory boards, medical education, and speaker engagements.

Scientific & Strategic Support

• Provide robust scientific support to FarmaMondo’s assets in the region.
• Develop and execute regional medical plans aligned with global strategy.
• Offer insight-driven contributions to market access, clinical operations, and commercial teams.
• Participate in dossier development and support inclusion in treatment guidelines and hospital formularies.

Training & Internal Collaboration

• Deliver training and ongoing scientific support to internal sales and commercial teams.
• Respond to complex HCP queries with accurate, balanced, and timely medical information.
• Collaborate closely with cross-functional teams including regulatory, compliance, business development, and global medical teams.

Business Development & Market Insights

• Support the regional team in the assessment of new business opportunities from a medical and scientific perspective.
• Assist in creating business cases using real-world evidence, patient journey mapping, and health economics data.
• Translate medical insights into actionable business opportunities.

Oversight Regulatory Affairs, Quality Assurance and Pharmacovigilance

• Provide regional oversight of regulatory strategy and operations to ensure timely product registration, importation, and compliance.
• Act as liaison between local regulatory authorities and FarmaMondo global teams.
• Ensure medical input into regulatory dossiers, labeling, and risk management plans.
• Support regulatory submissions, variations, renewals, and license maintenance in collaboration with global RA teams.
• Ensure alignment with Good Distribution Practice (GDP) and quality standards for the handling of medicinal products in the region.
• Collaborate with the global QA function to manage audits, inspections, and quality incidents.
• Oversee local pharmacovigilance activities to ensure compliance with global and local regulations.
• Act as a regional point of contact for safety-related issues and coordination with FarmaMondo’s global PV team
• Serve as the Local Compliance Lead, ensuring compliance with FarmaMondo’s policies and external regulations.

QUALIFICATION AND EXPERIENCE

• Degree in medical science MD, or PhD
• 15- 20 years as a Medical Adviser/ Manager/ Director, in MNCs based in India
• Experience in Neurology Pediatrics, Rare Disease, Hematology and Oncology, preferred.
• Previous exposure or experience collaborating with QA, RA, or PV teams is highly desirable.
• Familiarity with regulatory frameworks and access pathways in India and South Asia.

SOFT SKILLS

• Strong interpersonal and communication skills, with the ability to influence across functions and cultures.
• Business acumen combined with scientific rigor and ethical integrity.
• Strong organizational and problem-solving abilities, with a proactive mindset.
• Proficiency in digital tools and systems relevant to Medical Affairs and Regulatory functions.