Associate DRA Manager

Job description

Job Description

• Ensure submission for product registrations or variations are carried out in a timely manner in compliance with internal and external regulatory requirements. • Manage and respond to product regulatory questions. • Manage and liaise with local regulatory authorities with regards to manufacturing site/ bioequivalence centres inspections where necessary. • Liaise with local regulatory authorities and Regional Regulatory Affairs to deliver timely and commercially advantageous license approvals. • Manage labelling text and packaging components to ensure compliance with local registered details and corporate prescribing information, as well as maximizing the commercial value of the label. • Ensure compliance with local, regional and corporate regulatory SOP's and other processes. • Providing input into the global regulatory strategy and identifying country specific requirements for successful regulatory filings for new medical devices/ products including life cycle management and renewals where required.• Involves in overall quality responsibility and executing activities in accordance with the Quality Management System, engagements to the local launch processes to ensure imported products are launched on schedule and in compliance with regulatory, Malaysia GDPMD, safety, health and environmental and corporate quality standards from medical device registration, importation through to commercialization and distribution. • Informing CMO&PS of all contracts and partners where PV agreements are to be set in place. For the avoidance of doubt, this includes agreements for Novartis Group Products and for Products with third Party MAH /CT Sponsors. • Ensuring that metrics and Key Performance Indicators relevant to the PV System, for activities that are the responsibility of the MAH/CT Sponsor are provided to CMO&PS as required by applicable SOPs. • Implementing CAPAs derived from audits / inspections as required. • Transmission of investigator notifications to the National Competent Authorities, Ethics Committees/Institutional Review Boards and/or Investigators as per local regulatory requirements.
Position Title

Associate DRA Manager

Desired profile

Minimum requirements

• Tertiary qualified – Pharmacy or Science (majoring in life science or chemistry) with or without post-graduate qualifications. • Specific qualification in a regulatory discipline. • Fluent in English and Bahasa Melayu both in spoken and written. • Possess Pharmacy license will be an added advantage. • Experiences: 3-4 years experience as an associate/ manager in regulatory affairs dealing with a wide variety of registration projects and issues.
Job Type

Full Time
Country

Malaysia
Work Location

Petaling Jaya
Functional Area

Research & Development
Division

SANDOZ
Business Unit

COMMERCIAL OPS APAC SZ
Employment Type

Regular
Company/Legal Entity

NOV MALAYSIA