Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory strategies to ensure compliance with international and regional regulations . Prepare, review, and submit regulatory documents in line with global requirements (US, EU, and emerging markets). Liaise with regulatory authorities to address queries and obtain timely approvals. Monitor evolving regulatory guidelines and industry trends , assessing their impact on product development and commercialization. Partner with R&D, Quality, Clinical, and Legal teams to provide regulatory insights throughout the product lifecycle. Support documentation for clinical trials , including protocols, investigator brochures, and informed consent forms. Conduct risk assessments and provide recommendations for safety reporting and compliance obligations. Participate in audits and inspections , driving corrective and preventive actions as needed. Provide regulatory training and guidance to internal stakeholders to enhance compliance awareness. Qualifications & Requirements Education: Bachelor’s degree in Pharmacy or a related scientific field (Master’s preferred). Experience: 7 - 8 years in pharmaceutical regulatory affairs within a global organization. Strong knowledge of FDA regulations (21 CFR Part 11), ICH guidelines, EMA, and regional market requirements . Demonstrated success in regulatory submissions leading to product approvals. Proven project management skills , with the ability to manage multiple projects in a dynamic environment. Excellent written and verbal communication skills for engaging internal teams and external authorities. Strong analytical, problem-solving, and decision-making abilities. Proficiency in regulatory information management systems and related tools.
Job Description Manager / Sr. Manager (Contract Manufacturing & Quality Compliance) Location: Pune Department: Manufacturing & Quality Reports To: Head – Operations / Quality Role Overview We are seeking an experienced and proactive professional to manage and coordinate production activities at contract manufacturing sites. The ideal candidate will have strong expertise in production planning, quality systems, regulatory compliance, and cross-functional collaboration to ensure timely supply of high-quality products in alignment with business objectives and global regulatory expectations. Key Responsibilities Production & Planning Manage and oversee production planning at contract manufacturing sites to achieve productivity and supply targets. Collaborate with internal teams and CMOs (Contract Manufacturing Organizations) for on-time execution of manufacturing schedules. Quality & Compliance Establish, monitor, and enhance quality systems at contract sites ensuring adherence to cGMP and international regulatory requirements. Promote a culture of quality and compliance across partner sites, ensuring readiness for export market audits. Review batch manufacturing records and ensure product quality in line with cGMP guidelines. Oversee shop-floor compliance, reviewing incidents, deviations, and change controls for timely closure. Drive resolution of quality audit observations, market complaints, and CAPA implementation. Ensure robust quality systems that deliver zero critical/major complaints. Technology Transfer & New Products Coordinate with technology transfer teams for new product introductions and product transfers to CMOs. Support smooth and timely execution of technology transfer activities to meet market and business requirements. Training & Capability Development Conduct training programs to upskill site teams and ensure preparedness for regulatory inspections. Process Improvement & Cost Optimization Identify and implement continuous improvement opportunities for efficiency, process optimization, and cost reduction at CMO sites. Vendor & Market Engagement Engage with vendors, industry stakeholders, and potential third-party manufacturers to strengthen the vendor network and ensure future scalability. Desired Candidate Profile Education: B.Pharm / M.Pharm / M.Sc. in Pharmaceutical Sciences or related discipline. Experience: 8 - 10 years in pharmaceutical manufacturing, quality assurance, or contract manufacturing operations. Strong knowledge of cGMP and global regulatory guidelines (USFDA, EMA, MHRA, etc.). Proven experience in managing contract manufacturing sites and handling regulatory audits. Exposure to technology transfer, process improvement, and vendor management. Demonstrated leadership, communication, and problem-solving abilities. Key Competencies Excellent knowledge of pharmaceutical production and quality systems. Strong project management and coordination skills. Ability to manage multiple stakeholders and vendors effectively. Analytical mindset with a balance of compliance and cost optimization. Commitment to fostering a strong culture of quality and compliance.