Wockhardt Ltd.

Company Description Wockhardt is a global pharmaceutical and biotechnology organization with full-fledged operations in several countries, including the USA, UK, Ireland, and France. The company focuses on innovation to develop medicines and products that improve the quality of people's lives. Wockhardt's strategic vision aims to create a healthier world through medical breakthroughs and value for stakeholders. Role Description This is a full-time on-site role for a Sr. Manager/ AGM - API Business at Wockhardt Ltd. based in Mumbai. The role involves day-to-day tasks associated with managing and overseeing the API business operations within the pharmaceutical and biotechnology sectors. Qualifications Medicine, Medical Affairs, and Medical Education skills Research and Market Access experience Strong analytical and problem-solving skills Excellent communication and presentation skills Ability to work collaboratively in a team setting Master's degree in Pharmaceutical Sciences, Life Sciences, or related field Interested candidate can share resume on "monalim@wockhardt.com" Regards, Monali HR Wockhardt

TITLE: - Lead Medical Affairs - Clinical Trials -Dermatology (MD) JOB OBJECTIVE : This individual will serve as the primary medical expert for assigned clinical trials within the dermatology therapeutic area, bridging the gap between clinical development, commercial teams, and external stakeholders. The role requires a strong understanding of clinical research methodologies, regulatory requirements, and the ability to translate scientific evidence into actionable medical strategies Location :Bandra Mumbai Responsibilities Provide medical and scientific expertise for the design, execution, and interpretation of clinical trials (Phases I-IV) in Dermatology & Venereology in India Ensure medical oversight of ongoing clinical studies, including safety monitoring and data review, adhering to GCP and Indian regulatory guidelines (CDSCO). Collaborate with global and local R&D/Clinical Development teams on clinical strategy and protocol development. Engage with Key Opinion Leaders (KOLs) and healthcare professionals, disseminating scientific information and gathering market insights. Contribute to publication strategies and deliver scientific presentations of clinical trial data. Ensure all medical affairs activities comply with industry regulations and company policies in India. Qualifications MBBS + MD (specialization in Dermatology or DDVL ) Total 8- 10 years of experience and minimum 1 year of clinical trial or 10+ medical affairs experience in the pharmaceutical industry. Skills & Competencies: In-depth knowledge of clinical trial methodology, study design, and statistical principles. Thorough understanding of ICH-GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA, Indian regulations). Strong scientific and medical acumen in Dermatology, including disease pathology, current treatment landscapes, and emerging therapies. Interested Candidate can share resume on "monalim@wockhardt.com" Regards, Monali M Corporate HR

The Lead Medical Affairs - Clinical Trials - Dermatology (MD) will serve as the primary medical expert for assigned clinical trials within the dermatology therapeutic area, bridging the gap between clinical development, commercial teams, and external stakeholders. Your role will require a strong understanding of clinical research methodologies, regulatory requirements, and the ability to translate scientific evidence into actionable medical strategies. You will be based in Bandra, Mumbai, and your responsibilities will include providing medical and scientific expertise for the design, execution, and interpretation of clinical trials (Phases I-IV) in Dermatology & Venereology in India. You will ensure medical oversight of ongoing clinical studies, including safety monitoring and data review, adhering to GCP and Indian regulatory guidelines (CDSCO). Collaboration with global and local R&D/Clinical Development teams on clinical strategy and protocol development will be essential. Engaging with Key Opinion Leaders (KOLs) and healthcare professionals, disseminating scientific information, and gathering market insights will also be part of your responsibilities. Additionally, you will contribute to publication strategies and deliver scientific presentations of clinical trial data while ensuring that all medical affairs activities comply with industry regulations and company policies in India. To qualify for this position, you should hold an MBBS + MD with a specialization in Dermatology or DDVL. A total of 8-10 years of experience with a minimum of 1 year in clinical trials or 10+ years in medical affairs in the pharmaceutical industry is required. In-depth knowledge of clinical trial methodology, study design, and statistical principles, along with a thorough understanding of ICH-GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA, Indian regulations), will be essential. Strong scientific and medical acumen in Dermatology, including disease pathology, current treatment landscapes, and emerging therapies, is also necessary. If you meet the qualifications and are interested in this opportunity, please share your resume at "monalim@wockhardt.com". Regards, Monali M Corporate HR,

Company Description Wockhardt Ltd. is a global pharmaceutical and biotechnology organization committed to providing affordable, high-quality medicines. Headquartered in Mumbai, India, Wockhardt has a multi-ethnic workforce of 3000 associates across 21 nationalities. The company operates 3 research centers and 12 manufacturing plants, with a strong presence in the USA, UK, Ireland, and France. Wockhardt focuses on innovation, using science and technology to develop medicines and products that enhance the quality of life for millions worldwide. Position: Manager / Asst. Manager - Regulatory Affairs Location: Chhatrapati Sambhajinagar (Aurangabad), Maharashtra Qualifications: Master's degree in Pharmacy, Life Sciences, or related field Experience: 8-12 years experience in Regulatory Affairs in Emerging Market filings Role Description This is a full-time, on-site role for a Regulatory Affairs Manager located at Chhatrapati Sambhajinagar (Aurangabad) Maharashtra. This position will be responsible for ensuring regulatory compliance, preparing and submitting regulatory documents, and maintaining quality systems. The role requires close collaboration with cross-functional teams to meet regulatory requirements and ensure the successful registration and approval of pharmaceutical products. Desired : 1. Experience in authoring CMC sections of dossier for drug substance and drug product 2. Experience in - handling applications including regional modules and queries from various health authorities in emerging markets (Asia/Africa/MENA/LATAM) 3. Well versed with ACTD/eCTD formats of applications, change control and life cycle management 4. In-depth understanding of clinical and non-clinical module