Piramal is Hiring for Executive Regulatory Affairs Labelling and has issued notification to accept Applications. The Piramal Group is a diversified global business conglomerate, which has presence across various sectors such as healthcare, life sciences, drug discovery, healthcare information management, specialty glass packaging, financial services and real estate.Interested and eligible candidates required to fill application form in online with Education and personal details and submit application along with resume .Job application form link provided at the end of post. Eligibility for the Multiple Position as follows.
Vacancy summary details :
- Company Name: Piramal
- Location :India-Kurla
- Post Name: Executive Regulatory Affairs Labelling
- Department: Regulatory Affairs
- Qualification: BS/MS Degree in a science/Pharma or related field
- Experience: 2 to 05 years
- No of Vacancies: Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 03/02/2021
- Closing date for online Application : Apply as soon as possible
- Date of examination: NA
- Time and Venue :NA
- Mode of application : online
- Selection Process: Shortlisted candidates may called for selection process ( Personal interview , Group discussion , etc…,)
- Ensures all artworks and labeling (labels, cartons, package inserts, patient package inserts) required are accurate and compliant by managing evaluations, maintenance, reviews and approvals with cross-functional teams for regulatory submissions.
- Understands and applies Canadian and US requirements for Text of Artwork, Packaging Insert and Medication guide preparation and review
- Reviews ANDA’s, amendments, supplements and annual reports to FDA
- Manages required labeling updates, proofreading, and version control
- Maintains country/regional labelling in compliance with Piramal Labelling processes and external requirements such as management of the International PI document, US PI and EU PI (for Centralized, Mutual Recognition and Decentralized procedure submissions)
- Coordinates Content of US Labeling/Drug Listing SPL generation and review for assigned products.
- Acts as subject matter expert in Piramal Global Labelling process for US/EU product information requirements.
- Authors documentation to support the Global Labelling Committee, as required
- Effective planning, prioritization, communication and delivery of quality labelling documents according to company timelines and submission requirements.
- Maintains knowledge of, and familiarity with FDA/EMA/key international market regulations and ICH labeling guidelines.
- Creates and update artwork files in line with HA requirements, distributors and business partner requests.