Regulatory Affairs Manager - Omani National
Career Level : Mid-level
Work Experience : 2-5 Years
Employment Type : Full Time
Monthly Salary : Unspecified
Education Level : Any
Your responsibilities include, but not limited to
Providing effective regulatory support to assigned country for new product registration, regulatory maintenance, and regulatory intelligence activities.
Implementing the registration of priority / new products in assigned country 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 Global Program Regulatory Managers (GPRMs) and supporting team in Hyderabad 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.
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
Provide necessary support 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
Initiate de-registration of pruned products without affecting the existing stock, coordinating with the respective countries and keeping informed the country managers
Update local registral of registration of manufacturing site as per new and mature products registration plan in the assigned countries
Co-ordinate with Hyderabad team, and MENA Regional office to ensure the registration renewal is submitted and approved in assigned countries as per the local regulations and the renewal plan.
Coordinate with logistics to ensure availability of correct pack in assigned countries.
Coordinate with GLU labelling lead to ensure labelling updates are submitted on time and in line with the local SOP.
Developing and maintaining Healthy professional relationships with MOHs in assigned countries.
Design and implement Health Authority management plan.
Effective identification and communication of regulatory changes and emerging opportunities in assigned countries.
Ensure full support to Global regulatory compliance initiatives in assigned country including - DRAGON updates and verification. - Registration and implementation of labelling changes. - Submission of Risk Management plans (RMP) and Periodic Safety Update Reports (PSURs).
We are looking for an Omani National to join our team who ideally has
Degree in Pharmacy.
Excellent English & Arabic required (oral and written).
2-3 years practical experience in BOQ regulatory affairs dealing with a wide variety of registration projects and issues.
Effective planning, organizational, and interpersonal skills.
Excellent negotiation skills.
Global Drug Development
REG AFFAIRS GDD
Novartis Pharma Services AG
Research & Development