**Main responsibilities:** _Indicate here the main job responsibilities with bullets points, avoiding Sanofi corporate jargon, acronyms, and gender-coded words (you can check if your language is neutral on this_ site (http://gender-decoder.katmatfield.com/) _)_ **_Product Dossier Management for Export Products:_** + _Writing of renewal dossiers of products manufactured in Indian CMO’s and exported to Russia, Ukraine, other CIS countries, Sri Lanka, Nepal, Latin American countries and other countries (if any addition) etc._ + _Writing and review of new product dossiers/ renewal dossiers for products manufactured at CMO’s based in South Korea, Thailand and Philippines for export markets._ + _Maintenance of the entire renewal dossier and new product dossiers for Indian CMO’s and overseas CMO’s._ + _Preparation and submission of post approval variations and send proper communication for implementation of the change._ + _Co-ordination with GRA, Country regulatory affiliates and COE for submission of dossier and supporting the required documentations._ + _Consolidate the regulatory strategy with the affiliate or the Global RA to submit the site change_ + _Updation of eTOC and dispatches dossiers through Veeva Vault._ + _Maintenance and distribution of Normative document to the responsible quality manager._ + _Implementation and follow GRA processes for all export product dossier management._ + _Life cycle management for all the products managed by EM India._ **_Regulatory status Management of Local products:_** + _Preparation of applications for procuring and renewal of Mfg. License/ WHO GMP. Certificates/COPP/Import license/ Sch. M GMP Certificates at External manufacturing sites_ + _Preparation of applications for Procuring Regulatory certificates for tender business (for Ext. manufacturing sites)._ + _Writing dossiers and co-ordination with CMO’s for dossier submission and management of domestic markets of Thailand and Korea._ + _Maintaining Regulatory status at External Manufacturing sites - preparation of applications to procure new manufacturing licenses/ additional products/ surrender of license which are no more required._ + _Sending Finished Product Samples/ working standards to Reg. Authorities when asked for Follow-up and replies to complaints received._ **_Artwork Review:_** + _Review and Approval of packing material artworks as per the Regulatory requirements._ + _Evaluate and anticipate the changes in artworks due to new regulation or guidance._ **_Documentation:_** + _Review of all the change controls initiated by QMS team w.r.t. Regulatory impact._ + _Initiation and evaluation of CCRF for global and regional products._ + _Co-ordinate & participate in change control committee._ + _To upload APQR in PQR workspace._ + _Review of any other documents having Regulatory Impact._ + _To maintain the regulatory database._ + _Prepare SOPs applicable to the department and maintain relevant records_ _Co-ordination with cross functional team for documentations required for submission of dossier or other applications to health authorities. Actively participate in the meeting organized by stake holders._ _Review of Pharmacopoeia changes impacting to EM India product portfolio and make action plan for Implementation of the change._ About you _List here ideally the must-haves criteria to be successful on the role. Don’t forget: the less criteria you will request, the more diverse candidates you will get in the pool._ + **Experience** : _(8-12 years of experience in Regulatory Affairs, Quality Assurance)_ + **Soft skills** : _Transversal skills,_ _Stakeholders management, Effective communication with external partners and ability to work independently._ + **Technical skills** : Regulatory Affairs, _Quality Assurance, Effective Analysing skills, Strong cross-functional collaboration, teamwork, and stakeholder management._ + _Managerial courage – ability to make difficult decision and implement successfully_ + **Education** : _(B.Pharm/ M.Pharm/ MSc in lifesciences)_ + **Languages** : _English, Hindi_ **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)