Job Description

The PositionCoordinate 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. 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.Tasks & Responsibilities

• Compile Market Authorisation application files for new products to the standards required for registration: collect, organise and analyse all the available information.
• Coordinate activities, define timing, and create registration files to support new product registrations as well as maintenance of approved biologicals, pharmaceuticals, or other regulated products in India.
• Liaise, network and collaborate with regulatory bodies and appropriate ministries to support new registration requirements and maintenance of current product portfolio.
• Plan, prepare, coordinate and work with the clinical team to execute studies in large or small animals to support registration of Boehringer Ingelheim products when needed.
• Review and verify packaging labels where applicable, revise labels per local regulatory authority requirement for registration and importation.
• Develop SOPs and provide regulatory input to product life-cycle planning.
• Maintain up-to-date legal and regulatory knowledge on the registration, import and sale of products.
• Register PV complaints in internal system tools as per SOP.
• Submit PSURs periodically as per local regulations.
• Develop SOPs and provide regulatory input to product life-cycle planning.
• 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.
• 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.
• All data related to MA should be updated in David, Birds and PRs should be updated from time to time.

Requirements

• Education: bachelor\'s degree, Master\'s degree Any post graduate degree (masters in Veterinary Sciences/pharmacy preferred).
• Familiarity with Drugs & Cosmetics Act & Rules with all relevant schedules
• Familiarity with guidelines for New Drug Approvals, Site Registrations and Import Licence.
• Good Understanding of India regulations.
• The candidate should have more than 2 years of Regulatory 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 \xe2\x80\x9cApply On Company website\xe2\x80\x9d 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

Boehringer Ingelheim