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Regulatory Affairs Manager

Novartis Pharma Services AG

Posted on May 2, 2019

2 - 5 years Muscat - Oman

Any Graduation. Omani

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Job Description

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817 million. That’s how many lives our products touched in 2018. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Your responsibilities include, but not limited to:

 NEW PRODUCT REGISTRATION
• Implementing the registration of priority / new products in Oman as per the agreed yearly objectives. With minimum supervision, evaluate, prepare and submit drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favourable outcome for registration and pricing.
• Coordinate with Regional Brand Regulatory Managers (RBRMs) in Basel and Hyderabad team to ensure having the registration requirements on time, hence fast submission / approval of new products.
• Coordinate with 3rd party suppliers for reference / related substance requests from the MOH.

 REGULATORY MAINTENANCE:

CMC, PT and Update - responsibilities:
• Receive and archive all ‘CMC, PT & Update’ that are dispatched by Regulatory team in Hyderabad
• Prepare and submit the ‘CMC, PT & Update’ that are relevant to assigned countries
• Ensure speedy approvals from Health Authorities in assigned countries
• Update local registration files with new ‘CMC, PT & Update’ approvals
• Update the approval to Regulatory team in Hyderabad and logistics for assigned countries, by sending notification.
• Coordinate with maintenance group - Team Leader to ensure correct and speedy implementation / correct consignments

New / Renewal of registration of Manufacturing site/s - responsibilities:
• Ensure new/renewal of registration of manufacturing site as per new and mature products registration plan in the assigned countries
• Request all required documentation concerning manufacturing site registration from Basel and support team in India
• Ensure speedy submissions and approvals of manufacturing site registration in the assigned countries in order to shorten time of product registration
• Update local archives for manufacturing site new/renewal of registrations
• Coordinate with maintenance group Team Leader to ensure correct and speedy implementation / consignments
• Develop and maintain good working relationship with DRA Team in Middle East Cluster and Indian DRA support team
• Develop and maintain strong relationship with the Health Authorities and Agents in the assigned countries

De-registration of pruned products - responsibilities:
• Initiate de-registration of pruned products without affecting the existing stock, coordinating with the respective countries and keeping informed the country managers
• Update local registration files with submission and/or confirmation from HA for the de-registration
• Update the de-registration to Regulatory team in Hyderabad and logistics for assigned countries

Divestment projects - responsibilities:
• Provide necessary supports to the responsible parties of the acquired companies for the Novartis products divested to them.
• Provide necessary maintenances (CMC/PT/Renewals) to the divested products until the divestment process is completed
• Necessary follow-ups until the Marketing Authorization of the divested product is transferred to the new company

Renewal:
• Co-ordinate with Renewal coordinator ME in Regional office to ensure the registration renewal is submitted and approved in assigned countries as per the local regulations and the renewal plan.

LABELING:
• Coordinate with logistics to ensure availability of correct pack in assigned countries.
• Sign PPMS ( material and shipment approval ).
• Answer manufacturing site queries concerning shipment approval/authorisations /pre license sale
• Coordinate with Logistics/ chain supply/ Artwork teams and manufacturing site to obtain valid artworks and implementation dates.
• Coordinate with Logistics/ chain supply/ Artwork teams and manufacturing site to ensure that the registered product specifications are compliant and being imported to each country.


R&D / Research & Development

Keywords

Manager Regulatory Affairs Regulatory Affairs Officer Regulatory Affairs Executive Executive Regulatory Affairs Regulatory Affairs Manager Regulatory CMC

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Novartis Pharma Services AG

817 million. That’s how many lives our products touched in 2018. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are fou nd when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.
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Contact

Name/ Designation:
Mehab Hassan - HRBP Gulf

Address: 5th Floor, Limitless Bldg, Al Khail Road
Dubai
United Arab Emirates
23510

LandLine:0097144357056

Fax:971--

Mob.:971--

Website https://www.novartis.com/


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