Regulatory Specialist

Company Description Alvita Pharma Private Limited (APPL) is a fast-growing pharmaceutical company headquartered in Mumbai, India, with a strong branded generics presence in over 25 countries across Africa, South East Asia, and Eastern Europe. The company markets more than 600 products spanning key therapeutic areas such as anti-malarial, gastrointestinal, antibiotics, cardiology, dermatology, and pain management. Alvita operates advanced formulation and product development research facilities in Mumbai and Vadodara, and a new manufacturing unit in Vadodara that is progressing toward European Union regulatory approval. Through a fully backward-integrated API joint venture, Alvita enhances cost efficiency while focusing on high-quality, affordable medicines and innovative molecules for the India market. The organization is guided by core values of reliability, trustworthiness, adaptability, accountability, and quality consciousness, with a strong commitment to long-term customer relationships and addressing unmet patient needs.
Role Description This is a full-time, on-site Regulatory Specialist role based at Alvita’s manufacturing and development facilities in Vadodara. The Regulatory Specialist will prepare, review, and submit regulatory dossiers and documentation for national and international markets, ensuring alignment with local and global regulatory requirements. Responsibilities include coordinating with cross-functional teams (R&D, Quality, Manufacturing, and Business Development) to gather technical data, maintain product registration databases, and support timely approvals for new and existing products. The role involves monitoring regulatory changes, interpreting guidelines, and advising internal stakeholders on compliance risks and mitigation strategies. The Regulatory Specialist will also support audits and inspections, contribute to labeling and packaging compliance, and help strengthen Alvita’s global regulatory footprint.
Qualifications
Candidates should possess strong expertise in Regulatory Compliance and Regulatory Requirements, with practical experience in pharmaceutical regulatory affairs.
Candidates should possess well-developed Analytical Skills to interpret regulatory guidelines, assess data accuracy, and support risk-based decision making.
Candidates should possess clear and professional Communication skills to collaborate with internal teams, external partners, and regulatory agencies.
Candidates should possess a solid foundation in Regulatory Affairs, including dossier preparation, product registration, and post-approval lifecycle management.
Relevant qualifications such as a degree in Pharmacy, Life Sciences, Chemistry, or a related field; postgraduate specialization in Regulatory Affairs is an advantage.
Knowledge of international regulatory frameworks (e.g., EU, WHO, emerging markets) and familiarity with generic product registrations is beneficial.
Strong attention to detail, documentation skills, and the ability to manage multiple projects and deadlines in a regulated environment.
Proficiency with regulatory documentation tools, MS Office, and basic data management systems; prior experience in a pharmaceutical manufacturing or R&D setting is preferred.

Work arrangement
No