10 Regulatory Intelligence Jobs

As a Safety & Pharmacovigilance Specialist I at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients participating in clinical trials and post-marketing programs. Your responsibilities will include entering information into PVG quality and tracking systems, preparing project plans, processing ICSRs according to SOPs, and generating accurate reporting of expedited reports in compliance with regulatory requirements. You will be responsible for triaging ICSRs, evaluating data completeness and accuracy, entering data into safety databases, compiling narrative summaries, and assessing information to be queried. Additionally, you will participate in activities such as literature screening, drug coding, MedDRA coding, quality review of ICSRs, and validation and submission of xEVMPD product records. Collaboration and communication are key aspects of this role, as you will work closely with data management staff, project teams, and external stakeholders to ensure the timely and accurate reporting of safety data. Your role will also involve serving as a subject matter expert in SPVG, mentoring new hires, and participating in audits/inspections as required. To be successful in this role, you should have a Bachelor's Degree in life science, nursing, pharmacy, or a related field, along with knowledge of safety database systems, medical terminology, and clinical trial processes. Proficiency in Microsoft Office Suite, excellent communication skills, attention to detail, and the ability to work both independently and collaboratively are essential. Minimal travel may be required for this position. Syneos Health is committed to providing a supportive and inclusive work environment where employees can authentically be themselves and contribute to meaningful projects that impact lives globally. Join us in our mission to accelerate customer success and make a difference in the world of biopharmaceutical solutions.,

As a Legal Compliance Specialist, your primary responsibility will be to ensure strict and proactive compliance with all Reserve Bank of India (RBI) regulations, other applicable NBFC laws, and relevant financial services statutes. You will be responsible for drafting, reviewing, negotiating, and managing a wide range of legal agreements with customers, vendors, partners, and other third parties to protect the company's interests. Conducting regular legal audits and reviews of vendor and partner agreements will also be a key aspect of your role to ensure adherence to terms and regulatory requirements. In addition, you will be tasked with effectively managing legal disputes, overseeing litigation processes, and coordinating with external legal counsel when necessary to represent the company's legal position. Your expertise will be sought in providing legal advice and support to internal departments such as Human Resources (HR), Secretarial, and Finance teams on various legal matters, policy frameworks, and compliance issues. It will be essential for you to stay up-to-date with evolving NBFC regulations, directives, and legal precedents to offer strategic legal insights and recommendations to the management. Your role will also involve identifying potential legal risks, assessing their impact, and developing mitigation strategies to safeguard the company's legal and financial interests. To qualify for this position, you should hold a Bachelor of Laws (LLB) degree and have at least 3-5 years of dedicated legal experience, preferably within the NBFC or Financial Services sector. Strong knowledge of NBFC regulations, RBI guidelines, and Indian corporate laws relevant to the financial services industry is a must. Excellent legal drafting, negotiation, and communication skills, both written and verbal, are essential for success in this role. You should be able to work independently, make confident decisions, and take ownership of legal responsibilities. Your work ethic should reflect a high level of professionalism and dedication to ensuring regulatory compliance and protecting the company's legal interests.,

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Support with preparation, review and compilation of CMC documents within the framework of regulatory affairs projects. Communicate with clients and Health Authorities in close cooperation with the respective lead. Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead. General guidance (consultancy) of colleagues and clients regarding CMC Services. Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues. Support with VDC strategy implementation and optimization. Comply with and support the maintenance of internal procedures. Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead. Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries. In agreement with Head of VDC REG providing on-site regulatory support to GCS clients. The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG. Handling of M3 databases Compilation/handling of wToCs for renewals/variations Drafting of eAFs and country information letters for dispatch packages Communication with local affiliates regarding local requirements Change assessments according to EU variation guideline CMC background preferred, IT affinity, very detail oriented, excellent communication skills Maintain knowledge and understanding of SOPs and current regulatory guidelines as applicable. What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The companys continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [HIDDEN TEXT]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Show more Show less

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Support with preparation, review and compilation of CMC documents within the framework of regulatory affairs projects. Communicate with clients and Health Authorities in close cooperation with the respective lead. Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead. General guidance (consultancy) of colleagues and clients regarding CMC Services. Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues. Support with VDC strategy implementation and optimization. Comply with and support the maintenance of internal procedures. Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead. Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries. In agreement with Head of VDC REG providing on-site regulatory support to GCS clients. The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG. Experience and Educational Requirements Several years experience, or demonstrable capability, in area of responsibility on similar field; advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks. University degree in Life Science. Minimum Skills, Knowledge and Ability Requirements Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures. Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision. Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation Ability to train and support junior/new colleagues in daily activities; ability to lead small projects with clearly defined scope. Ability to manage internal and external (client) relationships on operational / day-today working level as well as client&aposs team lead level. Good communication skills (written and verbally); capability to communicate issues and propose solutions. Confident appearance. English business fluent What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The companys continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [HIDDEN TEXT]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Show more Show less

As a Regulatory Compliance Specialist, your primary responsibility will be to ensure that company products adhere to relevant regulatory requirements, including those stipulated by USFDA, FDA, EMA, and local regulatory bodies. You will be tasked with preparing and submitting regulatory documents such as INDs, NDAs, and MAAs to regulatory agencies. Additionally, you will play a pivotal role in developing and executing regulatory strategies that support product development and commercialization efforts. Your role will also involve staying abreast of evolving regulatory standards and providing guidance to internal stakeholders based on regulatory intelligence. You will coordinate and oversee regulatory audits and inspections, as well as review and approve product labeling and advertising materials to ensure compliance with regulations. Regular communication with regulatory agencies, such as the FDA, to address inquiries and issues will be part of your duties. Furthermore, you will be responsible for managing regulatory documentation, including submissions, approvals, and correspondence. Providing regulatory training and guidance to internal teams and monitoring company activities for compliance with regulatory requirements are also integral aspects of this role. This is a full-time, permanent position with a day shift schedule and a yearly bonus. The work location for this role is in-person.,

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