A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Global Labeling Associate/Specialist
Job Description:
1. The GRA GL Manager is responsible for the global labelling activities of assigned Novartis Consumer Health Over-the-Counter (NCH OTC) products to provide high quality information to Health Care Professionals and consumers whilst minimizing product liability risks.
2. The GRA GL Manager is responsible for managing GRA PSUR input, preparation and updates of Product Information documents such as Core Data Sheet (CDS), Patient Information Leaflet (PIL), regional Summary of Product Characteristics (SmPC), Labelling Texts, and support to the GL planning.
3. The GRA GL Manager also manages the roll-out of updated product information documents and monitors their worldwide implementation (including CDS updates and amendments) for NCH OTC portfolio in order to achieve international harmonisation of Product Information for the Pharmaceutical, Food Supplement, Medical Device and Cosmetic products.
1. Global Product Information: Create and maintain regulatory compliant, competitive and up to date global labelling documents (CDS, SmPC, PIL and labelling texts for assigned products.
2. CDS Supporting Documents: Organise and lead the creation of high quality documents sup-porting changes to the CDS with internal and/or external experts including the preparation of responses to labelling-related Health Authority queries.
3. Global Labelling Committee (GLC): Present and defend proposed changes in global product information documents to the Global Labelling Committee (GLC) for review and approval.
4. Global Line Functions: Organise and lead Global Line Functions (GLFs) to reach consensus on global labelling matters and prepare supporting documents for CDS changes. Lead the GLC follow-up activities related to global labelling.
5. Interactions with local RA worldwide: Interact with Country Organization Regulatory Affairs (CO RA) and GRA Regions to ensure timely implementation of global labelling changes in local product information, and ensure international consistency and compliance with the CDS. Keep GRA Regions informed of roll-out and implementation progresses and inform them as well as theCDS TL in case of issues. Support CO RA for all labelling related HA negotiations.
6. Periodic Safety Update Report (PSUR): Provide global regulatory input and contribution to PSURs for assigned products, and follow up on potential CDS changes considered in PSURs.
7. CDS query management: Lead GLFs cross functional teams in responding to Health Authori-ties (HAs) for CDS queries.
8. Patient Information Leaflet (PIL): maintain regulatory compliant, competitive and up to date core PIL based on the CDS for selected global NCH OTC products.
9. Process Improvements: Review and adapt Novartis processes to changing requirements in Global Labelling.
Candidate Profile:
Minimum: MSc in Life Sciences/ M Pharm
Desired: Qualification in Medical Sciences (MBBS/MD/equivalent), or PhD in Life Sciences
MSc/ M Pharm with minimum 5 years experience in Regulatory Affairs, Medical Information or Project Management
Desired: MBBS/ PhD with at least 5 years of Regulatory/ Medical Writing/ Drug safety work experience
Excellent written and oral English
Additional Information:
Experience: 2-5 years
Location: Hyderabad
Education: M.Sc, M.Pharm, Ph.D, MBBS, MD
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 71828BR
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