Requirement: Regulatory Associate/ Regulatory Specialist – DRA (Global Labelling)
Job Location: Hyderabad / Secunderabad
Exp: 2-7years
Job Description:
The Regulatory Associate/ Specialist -Global Labelling-DRA (INDIA)is responsible to provide specific services to DRA-Global labelling for Novartis Pharma products, which include & are not limited to support Global Labelling Managers at Basel from India for providing the DRA-GL inputs (e.g. PSUR, PSB, CDS, BSS, BPL, IPL etc.) and support the GL planning and the monitoring of the worldwide implementation of corporate agreed product information changes (Core Data Sheet (CDS) updates and amendments) for international Novartis Pharma products in order to achieve international harmonization of Pharmaceutical Product Information.
Major Accountabilities (Describe the 5-7 main results of the role to be achieved )
-The position will support the Global Labelling activities.
-Support communication strategy within the DRA Hyderabad.
-Support key processes are in place and functioning efficiently to facilitate teamwork and communication.
-Work within the Support systems and processes to enable accurate documentation and data.
-Periodic Safety Update Reports (PSURs): Prepare and review regulatory contribution to PSURs for specific products to support GL Manager. Interact with DRA Country Pharma Organisations (CPOs) and European Regulatory Life Cycle Management (RLCM) to collect appropriate information for the PSURs.
-Compliance checks: Evaluate and communicate discrepancies between local and global labelling to support GL manager’s contribution to Product Stewardship Board (PSB) review.
-Basic Patient Leaflet (BPL), Basic Succinct statement (BSS): Maintain regulatory compliant, competitive and up to date BPL and BSS based on the Core Data Sheet for specific global Novartis Pharma products.
-International Package Leaflet (IPL): Preparation, updating and amending of the International Package Leaflets for all Pharma products in compliance with the Cora Data Sheet changes, as required for registration dossiers, registration samples and for use in export packs (includes the coordination of translations, proofreading of Artwork, and distribution of leaflets to CPOs).
-Post-Distribution Changes (PDC): Enter GL-related Post-Distribution Changes (PDCs) into DRAGON (Global regulatory compliance database).
-Competitor Product Information: Collect and analyse competitor labelling for specific Novartis Pharma products.
-Drug Interactions of Novartis Pharma products: Create and maintain database to assess drug interaction labelling between Novartis Pharma products.
-Reference checks: Review references quoted in draft Core Data Sheet (CDS) for specific Novartis Pharma products to ensure adequacy and quality
-Collaboration within DRA: For all activities: work in close collaboration with and support GL Managers (located at HQ in Basel).
Senior:
-Special expertise and seniority in the above listed activities.
-Training and coaching junior associates of Drug Regulatory Affairs – Global Labelling
Eligibility: Masters/ Bachelors degree in Pharmacy / Medicine / Life Sciences or equivalent (e.g. Pharmacy, Pharmacology, Biotechnology, Quality Assurance)
Desired:
-Excellent English required (oral and written). Knowledge of European languages beneficial.
-1 – 8 years practical experience (Medical affairs, Regulatory, Clinical or Quality Assurance)
-1 – 6 years knowledge of global regulatory and/or Medical & CMC documentation preparation experience for writing CTD module 4 & 5, Product Labelling, CTA/IMPDs, ANDAs, MAAs, INDs, BLAs and NDAs would be of advantage.
-Ability to critically evaluate data from a broad range of scientific disciplines.
-Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
-Ability to work successfully with extended, multi-national project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
-Effective planning, organizational, and interpersonal skills.
-Excellent written/spoken communication and negotiation skills.
-Computer literacy.
Company Name: Novartis Healthcare Pvt Ltd
Website: http://www.novartis.com
