**The Position** Coordinate for PR completion to obtain dossier. Preparing quality documents in timely and compliant manner to ensure zero rejections. Follow up with Regulators for speedy approval in India. To liaison with the Regulatory Authorities in order to ensure smooth process of drug registration. To adapt and align SOPs and process flows to the new policies and regulations. Ensure on-time testing of products at approved test labs in India and BNS. Ensure on-time filing of Form 3 and 5 for NLEM and pricing. **Tasks & Responsibilities** + Prepare registration plan as per LTF or Global strategic products registration. + Register PV complaints in internal system tools as per SOP. + Submit PSURs periodically as per local regulations. + Obtain dossiers and prepare documents as per checklist. + Follow up with regulators and consultant for speedy approval. + Ensuring all product registrations, renewals, artworks, PV complaints meets local regulations. + The job needs to fulfill regulations as laid down by CDSCO, Government of India, DGDA (Bangladesh)and Sri Lankan authorities. + PV complaints needs to follow SOP and timely closure and submission to local regulators. PSUR submissions to be completed on time as per regulatory requirements. + Regulatory affairs need to work with various internal teams like Global RA, Regional RA, Marketing, Technical, Manufacturing, Quality, Finance and Purchase. + Register new drugs and new indications in line with the business strategy. + Ensure regulatory compliance of packaging. + Responsible for creating and updating labelling of products. + To adapt and align our SOPs and process flows to the new policies and regulations released by health authorities. + Testing at IVRL / CDTL / or any government laboratory. **Requirements** + Education: Graduate Degree (preferably in Veterinary Sciences/Pharmacy); any post graduate degree (master’s in veterinary sciences /pharmacy preferred) + Familiarity with Drugs & Cosmetics Act & Rules with all relevant schedules + Familiarity with guidelines for New Drug Approvals, Site Registrations + Good Understanding of India, Bangladesh, Sri Lanka and Nepal guidelines for Industry + The candidate should have more than 7 years of Regulatory and Pharmacovigilance experience. + The candidate should possess skills related SUGAM on-line applications. + Good communication skills with fluency in English and Hindi + Position will work at Mumbai. READY TO APPLY? Click the “Apply On Company website” button. Create an account or sign in and continue to register your profile, upload your resume, and apply in the company site. For any technical issues or additional questions, contact HR Direct. (Note: resumes should not be submitted to HR Direct since job applications are not processed via email or phone call) HR Direct contact information: Phone: +91-22-7145-6700 Email: HRDirect.PH@boehringer-ingelheim.com All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.