5 Regulatory Strategies Jobs

At Lilly, the focus is on uniting caring with discovery to improve the lives of individuals worldwide. As a global healthcare leader headquartered in Indianapolis, Indiana, the organization is committed to developing and delivering life-changing medicines, enhancing disease management, and giving back to communities through philanthropy and volunteerism. The team at Lilly prioritizes putting people first and is dedicated to making a positive impact on a global scale. The Product Research and Development (PRD) organization at Lilly is instrumental in the development and delivery of quality medicines to patients. The diverse portfolio includes the development and commercialization of various medical products ranging from insulins to gene therapy systems. This multidisciplinary group collaborates closely with therapeutic business units and manufacturing teams to bring Lilly's clinical portfolio to patients worldwide. Located in Bengaluru, India, the Lilly Capability Centre India (LCCI) is a strategic investment aimed at attracting top talent from India's academic and professional landscape. The LCCI team works in tandem with the PRD team in Indianapolis to develop critical capabilities for Lilly and support the delivery of the organization's portfolio. As part of the PRD team, the role involves leveraging experience in solid drug product manufacturing unit operations to expedite the development of combination products and enhance manufacturability. Responsibilities include conducting risk assessments, defining critical quality attributes, implementing new manufacturing platforms, and designing manufacturing process control strategies. The position also entails leading development activities, collaborating with cross-functional teams, and contributing to regulatory strategies and submissions. The ideal candidate for this role possesses a Ph.D. in chemical engineering, pharmaceutical sciences, or a related field with relevant experience, or a B.S. or M.S. with extensive experience in a related field. Additional skills/preferences include familiarity with new platforms such as PAT and modeling tools, knowledge of oral drug delivery landscapes, project management experience, and demonstrated leadership abilities in a team setting. Lilly values diversity of thought and experience, encouraging creative solutions to address technical challenges. The organization is committed to engaging with the external environment and adopting innovative approaches across its drug product portfolio. The position may require some travel. Lilly is dedicated to providing equal opportunities for individuals with disabilities in the workforce. If accommodation is needed to apply for a position at Lilly, applicants can complete the accommodation request form for further assistance.,

As a Regulatory Compliance Specialist in the construction industry, your role will involve developing and implementing regulatory strategies to ensure compliance with all applicable laws and regulations. You will be responsible for monitoring and evaluating regulatory requirements for construction projects and providing guidance to project teams. In this position, you will coordinate with internal teams, external consultants, and regulatory authorities to obtain necessary approvals and permits. Your responsibilities will also include reviewing and interpreting regulatory documents, as well as communicating requirements to stakeholders. As a Regulatory Compliance Specialist, you will conduct audits and inspections to assess compliance with regulatory standards and implement corrective actions as needed. It will be crucial for you to stay updated on changes in regulatory requirements and proactively address potential compliance issues. Your role will also involve preparing and submitting regulatory reports and documentation in a timely and accurate manner. Collaboration with cross-functional teams will be essential to ensure regulatory compliance throughout the project lifecycle. To qualify for this position, you should have a Bachelor's degree in Civil Engineering, Construction Management, Regulatory Affairs, or a related field.,

This is a full-time on-site role for a Manager / Deputy Manager Regulatory Affairs located in Vadodara. As the Manager / Deputy Manager, your responsibilities will include developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. Your role will involve interacting with regulatory agencies, managing timelines, and ensuring that all products meet regulatory standards. Your key responsibilities will be to develop and direct global regulatory strategies for clinical, non-clinical, and CMC aspects. You will lead the preparation, review, and approval of submission documents for US FDA, EMA, Health Canada, Australia, and ANVISA. Providing strategic guidance on the impact of CMC changes on regulatory submissions and developing appropriate regulatory pathways will be crucial aspects of your role. Additionally, you will review and evaluate CMC documents, including specifications, batch records, stability data, and change controls. Collaboration with cross-functional teams to ensure regulatory compliance and timely submission will be essential. You will also participate in client discussions, training, and development activities as needed. Experience in handling teams and a total experience of 12 to 15 years is required for this role. Qualifications for this position include experience in regulatory strategy development and implementation, proficiency in preparing and submitting regulatory documents, a strong understanding of regulatory compliance, excellent organizational and timeline management skills, strong written and verbal communication skills, and the ability to interact effectively with regulatory agencies. Experience in the pharmaceutical industry is a plus, and a Bachelor's degree in Pharmacy, Chemistry, or a related field is required.,

The candidate will be responsible for researching, analysing, and summarizing complex regulatory information, translating it into insightful and compliant reports. You will research and monitor regulatory requirements, guidelines, and industry trends from agency websites. Additionally, you will analyse and interpret regulatory information, provide concise and accurate summaries, and prepare high-quality regulatory intelligence. It is important to maintain up-to-date knowledge of global regulations and standards, contribute to regulatory strategies, and ensure timely delivery of reports. Qualifications for this role include a BSc/B. Pharm in a related field such as Life Sciences, Pharmacy, Regulatory Affairs, or a similar discipline. Candidates should have at least 2 years of experience in scientific report writing, strong research and analytical skills, exceptional English written and verbal communication skills, attention to detail, and the ability to work with technical and scientific content. Time management, organizational skills, and familiarity with regulations and guidelines (e.g., US FDA, EMA, UK MHRA, ICH) are essential. A certification in regulatory affairs would be advantageous. This is a full-time position based in Gurgaon.,

Provide Leadership and coordinate with cross functional teams to deliver Safe,Effective & Regulatory compliant Products to customers following the QCDMSES (quality, cost, delivery, development, management, safety, environment Required Candidate profile BE or BTech. or high or equivalent Degree. MBA is added preference.Working Knowledge of Regulatory Resources & Added certifications Ex: RAPS, regulatory trainings and certifications. Working knowledge