5 Regulatory Intelligence Jobs

As the Director of Regulatory Research & Intelligence at Kamet Consulting Group, you will be responsible for leading and developing a team of research consultants in the life sciences and healthcare technology industry. Your role will involve overseeing regulatory intelligence, compliance support, and advisory services for clients in the pharmaceutical and medical device sectors. You will be the key authority for regulatory research activities in India, ensuring delivery excellence, quality control, and strategic insights. Your core responsibilities will include building and mentoring a team of research consultants, setting performance targets, and fostering their professional development. You will also be responsible for ensuring that all research, analysis, and regulatory intelligence meets global quality and compliance standards. Additionally, you will define and evolve the research agenda in alignment with regulatory trends and client priorities, oversee project delivery, and communicate complex regulatory insights to executive audiences. To qualify for this role, you should have an advanced degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field, with a preference for a PhD or MBA. You should have at least 10 years of experience in regulatory affairs, regulatory intelligence, or compliance within the pharma/medical devices industry, including 5 years in consulting and team management roles. Strong leadership skills, expert knowledge of global and Indian regulatory frameworks, exceptional communication abilities, project management experience, and an entrepreneurial mindset are essential for this position. Desired traits for the role include being well-read on regulatory and scientific literature, culturally adept in global teams, and having high ethical standards and a passion for quality in research and client service. Kamet Consulting Group offers a collaborative and innovative work environment, competitive compensation and benefits package, flexible working arrangements, and growth opportunities for all qualified applicants. Join us to contribute to meaningful technology in the life sciences domain and be part of a team committed to innovation.,

JD for Regulatory Affairs Executive We have requirement who have experience in AERB CDSCO BIS Plastic Waste ISO Share your cv - rekha@mi.konicaminolta.in

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.,

Assists in the maintenance of registrations and licenses of the products in RA systems and database such as SharePoint and other team folders as necessary. Performs labelling reviews and assisting in project creation in the Artwork Management system (WebCenter) as needed. Ensures timely submission of in renewal, site registrations and minor product submissions to relevant Health Authorities in APAC countries. Ensures effective communication across RA (top-down and botom-up) Ensures timely Veeva Vault update related to LCM activities such as MA renewal, site registration, and other minor product submissions as needed. Supports in the request of samples collection via K2 system. Generates regional reports, process vendor payments and other country-related requests. Provides support on other country regulatory and cross functional activities as necessary. Conducts timely regulatory intelligence search in the relevant countries and update Country Regulatory Tool system as necessary. Takes part in Regional/Global or local hub initiatives that are relevant to support the region and hub. Supports the review and revision of hub processes to achieve efficiency across hub. Able to travel as per business need. Other Activities: a) Strategy Alignment -For Site Registration submissions only, ensures alignment with country on submission strategy as required. b) Dossier Readiness - Performs labelling reviews and assists in project creation in Artwork Management system. c) Application Submission - Supports country in renewal and minor product submissions to relevant Health Authorities. - Assists overall the maintenance of registrations and licenses of the products in RA systems and database. - For Site Registration submissions only, ensures timely submission/dispatch of the dossier related to submission and timely Veeva Vault updates. d) Application Approval - Supports country in renewal and minor product submissions to relevant Health Authorities. - Assists overall maintenance of registrations and licenses of the products in RA systems and database. e) Product Maintenance - Assists overall hub in the maintenance of registrations and licenses of the products in RA systems and database. f) Others - Provides support on other country regulatory and cross functional activities. - Generates reports, request samples collection, process vendor payments Who you are: Bachelors or Masters in Pharmacy OR p.HD Min 5-10 Years of experience in Indian Regulatory Market Fluent in written and spoken English Experience in CDSCO, Import and State FDA

Job Summary The TM-Pharmacovigilance role involves ensuring the safety and efficacy of pharmaceutical products through vigilant monitoring and analysis. With a focus on regulatory intelligence the candidate will contribute to maintaining compliance and enhancing customer service. This hybrid role requires rotational shifts and proficiency in English with no travel obligations. Responsibilities Monitor and analyze adverse drug reactions to ensure patient safety and product efficacy. Collaborate with cross-functional teams to gather and interpret regulatory intelligence data. Provide expert guidance on pharmacovigilance processes to enhance customer service experiences. Develop and implement strategies for effective risk management and mitigation. Ensure compliance with global regulatory standards and guidelines in pharmacovigilance activities. Oversee the preparation and submission of regulatory reports and documentation. Conduct thorough research to support the development of new pharmacovigilance methodologies. Facilitate communication between stakeholders to ensure seamless regulatory affairs processes. Utilize advanced analytical tools to assess and improve pharmacovigilance systems. Lead initiatives to optimize research and development efforts in drug safety. Support the integration of regulatory intelligence into strategic planning and decision-making. Drive continuous improvement in pharmacovigilance practices to benefit public health. Maintain up-to-date knowledge of industry trends and regulatory changes. Qualifications Possess strong expertise in customer service within the pharmacovigilance domain. Demonstrate proficiency in regulatory intelligence and its application in drug safety. Have experience in regulatory affairs and research and development as a nice to have skill. Exhibit excellent communication skills in English both written and spoken. Show ability to work effectively in a hybrid work model with rotational shifts. Display a commitment to maintaining high standards of compliance and safety. Bring a proactive approach to problem-solving and process improvement. Certifications Required Certified Pharmacovigilance Professional Regulatory Affairs Certification - B.Pharm/M.Pharm