Specific Responsibilities

We are seeking a highly driven Medical Affairs professional to provide scientific and clinical expertise across assigned therapy areas. The role involves delivering non-promotional medical support, engaging key external stakeholders, and partnering cross-functionally to strengthen product strategy and customer relationships.

Key Responsibilities:-

Scientific Engagement

• Interpret and communicate clinical data, research findings, and therapy-area updates to internal and external stakeholders
• Maintain deep technical knowledge of company and competitor products
• Evaluate scientific literature and study methodologies
• Provide medical and scientific support to internal and external stakeholders.

. Medical Education & Communication

• Conduct scientific discussions based on clinical data and published literature.
• Support advisory boards, CMEs, conferences, and medical meetings.
• Respond to unsolicited medical queries in compliance with regulatory guidelines.

Clinical & Research Support

• Collect and share field insights with cross-functional teams (Marketing, Sales, R&D).
• Maintain clear distinction between promotional and non-promotional engagement.

Compliance & Documentation

• Ensure all interactions comply with regulatory and company policies.
• Maintain accurate records of KOL engagements and scientific interactions.

Cross-Functional Collaboration

• Partner with Sales and Marketing teams to provide scientific training and product knowledge.
• Contribute to the development of medical strategies aligned with business objectives.
• Contribute to process improvements within Medical Affairs.

Qualifications & Experience

• Education: BDS / B.Pharm / M.Pharm / Pharm.D
• Strong knowledge of clinical research and therapeutic area expertise.
• Excellent communication and presentation skills.
• Willingness to travel extensively (Predominantly field-based role, with 90% time spent on field.)

Key Competencies

• Scientific acumen
• Stakeholder management
• Analytical thinking
• Ethical and compliance orientation
• Strong interpersonal skills

Role Overview

We are seeking an experienced Compliance Officer to lead the design, implementation, and oversight of the compliance framework for our India business. The role will focus on ensuring adherence to the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), applicable laws, and internal ethical standards, while supporting the organization’s commitment to responsible and ethical business conduct.

This is a hands-on role requiring strong pharmaceutical industry experience, practical understanding of field operations, and the ability to influence stakeholders across commercial, medical, and support functions.

Key Responsibilities:-

• Establish, implement, and continuously enhance the India compliance framework in line with UCPMP guidelines, company policies, and applicable regulations.
• Act as the subject-matter expert on UCPMP and ethical promotional practices for the India business.
• Develop and roll out compliance policies, SOPs, and guidance documents relevant to sales, marketing, medical, and third-party interactions.
• Design and deliver compliance training programs for employees, including field force, leadership teams, and new joiners.
• Review and advise on promotional activities, HCP engagements, sponsorships, grants, events, and related initiatives.
• Conduct compliance risk assessments, monitoring, and audits of India operations; identify gaps and recommend corrective actions.
• Manage investigations related to potential compliance breaches and support disciplinary or remediation processes as required.
• Serve as a trusted advisor to business leaders, providing pragmatic compliance solutions while enabling business objectives.
• Liaise with Legal, HR, Internal Audit, and external stakeholders as needed.
• Track regulatory developments related to UCPMP and pharmaceutical compliance in India and proactively update internal practices.

Qualifications & Experience

• 8- 10 years of professional experience, with significant exposure to compliance, ethics, legal, or audit roles within the pharmaceutical industry.
• Prior hands-on experience working with UCPMP guidelines is essential.
• Strong understanding of pharmaceutical sales and marketing practices in India.
• Experience in setting up or strengthening compliance frameworks, preferably in a growing or transforming organization.
• Bachelor’s degree required; Law, Pharmacy, MBA, or related qualifications preferred.
• Professional certifications in compliance or ethics are an added advantage.

Key Competencies

• High ethical standards and strong professional integrity.
• Ability to work independently and manage complex compliance matters.
• Strong stakeholder management and communication skills.
• Practical, solution-oriented approach to compliance.
• Confidence to challenge, influence, and educate senior business leaders.
• Strong documentation, analytical, and training capabilities.

What We Offer

• Opportunity to play a critical role in shaping the compliance culture of the India business.
• High visibility role with direct interaction with senior leadership.
• A values-driven environment committed to ethical and responsible healthcare practices.

Job Summary

We are seeking a dynamic Product Manager to drive brand strategy, market growth, and product lifecycle management for our pharmaceutical portfolio. The role involves developing marketing plans, analyzing market data, and collaborating with cross-functional teams to ensure successful brand performance.

Key Responsibilities:-

• Develop and execute annual brand plans.
• Analyze market trends, competitor data, and sales performance (IQVIA/IMS).
• Plan and execute product launches and promotional campaigns.
• Develop marketing materials in compliance with regulatory guidelines.
• Coordinate with Sales, Medical, Regulatory, and Supply Chain teams.
• Conduct field visits and provide training to the sales team.
• Monitor marketing budgets and track ROI.

Qualifications

• Bachelor’s degree in pharmacy / Life Sciences (B.Pharm / B.Sc / M.Pharm preferred)
• MBA in Marketing (preferred)
• 2 - 5 years of pharmaceutical marketing experience.
• Experience in product launches will be an added advantage.

Required Skills & Competencies

• Strong analytical and data interpretation skills
• Strategic thinking and brand management expertise
• Excellent presentation and communication skills
• Understanding of pharmaceutical regulatory compliance
• Stakeholder management skills
• High ownership and execution capability

About Exeltis

Exeltis is a global pharmaceutical company focused on women's health, central nervous system, and cardio-metabolic therapeutic areas. As part of the Insud Pharma group, we are committed to improving patient outcomes through innovative, high-quality medicines.

Role Summary

We are seeking an experienced Deputy General Manager – Business Development to drive growth through strategic partnerships, in-licensing opportunities, and market expansion initiatives across India. This role will identify and evaluate new business opportunities, negotiate deals, and build long-term relationships with partners, distributors, and key stakeholders.

Key Responsibilities

• Strategic Planning – Develop and execute the business development strategy aligned with Exeltis India's growth objectives and global portfolio priorities.

• Opportunity Identification – Scout, evaluate, and prioritize in-licensing, out-licensing, co-marketing, and distribution partnership opportunities in the Indian pharmaceutical market.

• Deal Negotiation – Lead end-to-end deal structuring, negotiation, and closure, including commercial terms, licensing agreements, and strategic alliances.

• Market Intelligence – Monitor competitor activity, regulatory changes, and market trends to identify white-space opportunities and inform portfolio decisions.

• Stakeholder Management – Build and maintain relationships with pharmaceutical companies, API suppliers, contract manufacturers, KOLs, and industry bodies.

• Cross-Functional Collaboration – Work closely with Marketing, Regulatory, Medical Affairs, Supply Chain, and Finance to ensure seamless integration of new products and partnerships.

• Due Diligence – Conduct commercial, regulatory, and financial assessments of potential opportunities; prepare business cases and investment proposals for leadership review.

• Revenue Accountability – Own top-line targets for business development initiatives and track performance against agreed milestones.

Qualifications & Experience

• Education – B.Pharm / M.Pharm / MBA (Pharma/Healthcare preferred); advanced degree is a plus.

• Experience – 12–18 years in the pharmaceutical industry, with at least 5 years in business development, strategic partnerships, or portfolio management.

• Domain Knowledge – Strong understanding of the Indian pharmaceutical market, regulatory landscape (CDSCO/DCGI), and branded generics business model.

• Track Record – Demonstrated success in closing licensing, co-promotion, or M&A deals.

• Skills – Excellent negotiation, financial modelling, and presentation skills; ability to influence senior stakeholders.

• Network – Established relationships with Indian and multinational pharmaceutical companies.

What We Offer

• Opportunity to shape the growth trajectory of a global pharmaceutical brand in India

• Competitive compensation with performance-linked incentives

• Collaborative, entrepreneurial work environment

• Exposure to global teams and cross-border projects

About INSUD PHARMA

INSUD PHARMA operates across the entire pharmaceutical value chain, bringing specialist knowledge and experience in scientific research, development, manufacturing, sales, and commercialisation of a broad range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value in both human and animal health. Our activities are organised in three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries. We are committed to innovation and sustainable development to deliver solutions that positively impact global health.

Exeltis, our branded pharmaceuticals division, focuses on therapeutic areas including Women's Health, Central Nervous System, and Cardiometabolic conditions, delivering high-quality branded generics, innovative molecules, and specialty products to patients worldwide.

What We're Looking For

We are seeking a Regulatory Affairs – Chief Manager to lead the regulatory strategy for Exeltis India's product portfolio—spanning branded generics, new chemical entities, fixed-dose combinations, and biosimilars—ensuring compliance with Indian regulatory requirements while aligning with global standards.

Key Responsibilities

Regulatory Strategy & Compliance

• Monitor changes in the Indian regulatory landscape (CDSCO, DCG(I), state FDA requirements), assess their impact on Exeltis India's portfolio, and propose solutions to maintain compliance

• Define regulatory strategy for product registrations, line extensions, and lifecycle management in coordination with Management, Business teams, and global Regulatory Affairs

• Interpret and communicate legislative changes under the Drugs and Cosmetics Act, New Drugs and Clinical Trials Rules 2019, and related guidelines affecting product registration, manufacturing, or development

Submissions & Approvals

• Prepare, review, and approve regulatory submission documents including CTD dossiers, Form 44/45, clinical trial applications, marketing authorisation applications, and import licences as per Schedule Y and current CDSCO guidelines

• Lead submissions for branded generics, new drugs, fixed-dose combinations, and where applicable, biosimilar products

• Manage post-approval variations, renewals, and periodic safety update reports (PSURs)

• Coordinate state-level licensing requirements (Form 20B/21B) for manufacturing and sales

Health Authority Engagement

• Lead engagement with CDSCO during pre-submission meetings, Scientific Advice procedures, and responses to queries and deficiency letters

• Coordinate with Subject Expert Committees (SECs) and manage timelines for New Drug Advisory Committee reviews

• Build strong collaborative partnerships with CDSCO, state licensing authorities, and approved testing laboratories

Risk Management & Cross-Functional Collaboration

• Identify and mitigate regulatory risks, adapting strategies to evolving regulations and Health Authority feedback

• Support the review of licence agreements, site master files, and quality agreements for Indian operations

• Collaborate with Quality Assurance, Pharmacovigilance, Medical Affairs, and Supply Chain teams to ensure compliant product launches

• Support product launch activities, ensuring regulatory risks are managed with appropriate action plans

Operations & Digitalisation

• Organise the regulatory submission schedule and coordinate with global Regulatory Affairs teams to align Indian filings with international timelines

• Manage external consultants, CROs, and vendors for regulatory activities in India

• Drive digitalisation within the department, including SUGAM portal submissions and electronic document management systems

• Participate in product plan development, regulatory strategy, and CMC documentation in line with Indian Pharmacopoeia and ICH-aligned requirements

Qualifications

• Bachelor's or master’s degree in pharmacy, Life Sciences, or a related discipline

• 5+ years of experience in Regulatory Affairs within pharmaceuticals or biotech, with hands-on experience in CDSCO submissions across multiple dosage forms

• Strong working knowledge of the Drugs and Cosmetics Act 1940, New Drugs and Clinical Trials Rules 2019, CDSCO guidelines, and Schedule Y requirements

• Experience with SUGAM online portal for regulatory submissions

• Familiarity with ICH guidelines (CTD format) and their adaptation to Indian regulatory requirements

• Experience handling branded generics, new drugs, FDCs, and/or biological products preferred

• Excellent communication skills and ability to liaise effectively with CDSCO and state regulatory authorities

• Experience managing external consultants and cross-functional project teams

Preferred Experience

• Background in Exeltis therapeutic focus areas: Women's Health, CNS, or Cardiometabolic

• Prior experience with import registrations and coordination with overseas manufacturing sites

• Exposure to pharmacovigilance requirements and safety reporting in India