Job Description Summary
We are hiring for a RA Manager role in Oman. This role will provide effective regulatory support to Oman for new product registration, regulatory maintenance , and regulatory intelligence activities.
Job Description
Ø 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.
Ø 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.
QUALITY ASSURANCE RESPONSIBILITIES:
· Assist Quality Assurance Manager for QA issues in assigned countries.
Regulatory intelligence Responsibilities:
· Developing and maintaining Healthy professional relationships with MOHs in assigned countries.
· Monitor competitor activities.
· Establish and maintain the Health Authority stakeholder mapping.
· Establish and maintain regulatory country fact book.
· Design and implement Health Authority management plan.
· Effective identification and communication of regulatory changes and emerging opportunities in assigned countries.
· Ensure transparency in Health Authority communication and interaction.
· Ensure participation at relevant local trade association.
OTHERS:
· Ensure full support to Global regulatory compliance initiatives in BOQ including:
- DRAGON updates and verification.
- Registration and implementation of labelling changes.
- Submission of Risk Management plans (RMP) and Periodic Safety Update Reports (PSURs).
- Ensue submission of new Safety updates received from DRA Regional office
· Update logistics with the DRA related information for the completion of Notification of Introduction (NOI).
· Communicate pricing of new products / Re-pricing to local logistics department and global – operations department.
· Monthly update of the registration data sheet (RDS) for Oman based on “Global project list”, in order to have a plan for registration and/ or launch for new products. The same being a very important tool which provides a registration update to various departments (Marketing, Medical, logistics etc.), at any time.
· Monthly reporting regulatory activities to Head Regulatory affairs Department – ME cluster.
· Provide regulatory advice to country managers in Oman.
· Develop and maintain healthy working relationship with colleagues in DRA department and with other Novartis department both locally in the ME , Hyderabad DRA support team and with Head office.
· Develop and maintain strong relationship with the Health Authorities and Agents in the assigned countries
Skills Desired
Clinical Trials, Detail-Oriented, Drug Development, Life Science, Negotiation, Regulatory Compliance