Senior Specialist - Regulatory Affairs Sigma Aldrich Chemicals

5.0 - 10.0 years

7 - 11 Lacs

Mumbai

Work from Office

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

Posted 1 week ago

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TM-Pharmacovigilance Cognizant

6.0 - 7.0 years

27 - 42 Lacs

Mumbai

Work from Office

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

Posted 2 weeks ago

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