Role & responsibilities Regulatory Affairs Associate I Description: The Regulatory Affairs Associate I assist other members of Regulatory Affairs Management (RAM) and the Regulatory Therapy Area (TA) in obtaining and maintaining licences and applications in accordance with agreed regulatory strategy and client standards. The Regulatory Affairs Associate I is an individual contributor who applies regulatory domain knowledge and may work under supervision. Accountabilities/Responsibilities: Document management including uploading and tracking regulatory files and systems according to established “CLIENT”procedures and regulatory requirements Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches Be the interface with health authority (HA) and their systems for designated regulatory tasks e.g., management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA portals Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, certificates of pharmaceutical products, legal documentation, e.g., letters of authorisation, power of attorney, translations of regulatory documentation Provide support across the group for assigned non-drug project roles & responsibilities e.g., function as a designated point of contact or superuser Provide guidance and knowledge sharing within the RAM skill group If required, support in activities such as scheduling of regulatory submissions, PBRERs, etc. Minimum Requirements – Education and Experience Relevant qualification and/or experience in science Minimum 2 years of experience from biopharmaceutical industry, or other relevant experience Proficient verbal and written English Project management skills Experience in document management and tracking databases Preferred Experience Some regulatory/medical/technical experience Knowledge of “CLIENT”business and processes Some knowledge of “CLIENT”submissions, compilation, publishing and approval processes, standards, systems and tools Experience of collaborating with people from locations outside of India, especially Europe and/or USA Skills and Capabilities Good written and verbal communication skills in English Cultural awareness Proficiency with common document management tools Ability to work independently and as part of a team Focus on continuous improvement and knowledge sharing Internal and External Contacts/Customers Lead RPM and members of the Global Regulatory Execution Team (GRET) and Global Regulatory Strategy Team (GRST) Other R&D skill groups, e.g., GRO, Operations Regulatory, Patient Safety, Reg TA (GRL & Regional Leads) Marketing companies Health authorities External collaboration partners “client” Legal “CLIENT”vendors for translation, document authentication, etc. Reporting Relationship Direct Reports – None Indirect Reports – None Interested candidate may reach @ 9845914559 or drop your updated resume to below mail id Nithya_kumar@persolkelly.com Regards, Nithya CONFIDENTIAL NOTE: By submitting your resume or personal data, you acknowledge reading and agreeing to our Privacy Policy. You hereby provide voluntary consent to the collection, use, processing, and disclosure of your data by us and our affiliates, in line with the Privacy Policy. and applicable laws. If you wish to withdraw your consent or have any concerns, you may submit a request to our designated consent manager, as outlined in our Privacy Policy. We prioritize your privacy. SECURITY NOTE: We at PERSOLKELLY India or our representatives, do not ask job seekers for fees, personal banking information, or payments through unofficial channels. Official communications will only come from @persolkelly.com. Report any suspicious activity to Contactus_in@persolkelly.com. Click here to find out how you can safeguard yourself from job scams
