Deputy Manager- Regulatory Affairs- Medical Devices
An opportunity to work with a global leader in Renal Care.
Ann opportunity to grow to Head-RA/GA for the organisation
About Our Client
Our client is a global leader in the field of Renal Care Medical Devices.
1. Regulatory Planning
a) Regulatory Plan Development
Plan, review and recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for pipeline products of assigned portfolio based on regulatory expertise with country regulations & MOH processes.
Manage and ensure the country Regulatory Plans are in alignment with Product Teams & Area strategies, and the country's business plan.
b) Process Management
i) Coordinates the process with other functional members of the affiliate, sites and corporate to ensure timely availability of required documents and other requirements for dossier preparation.
ii) Active participation in cross-functional teams within the affiliate and provide regulatory expertise and insight to ensure regulatory timelines are met or improved.
2. Submissions and Approvals
a) Dossier Preparation
Prepare a quality regulatory dossier and submit within the planned affiliate timelines.
* Request and obtain the various regulatory items needed for the local submission
* Prepare/format the dossier to ensure it meets local requirements
* Implement the submission and archive appropriately
b) Gain Regulatory Approval
Gain MoH approvals to meet the affiliate product launch plans and ensure product maintenance.
* Provide quality responses to the Ministry of Health (MOH) by the due date
* Complete regulatory approval process and gain product licenses
* Communicate Product approval
* Archive submission dossier and approval documents
* Track post approval commitment, if any
* Perform regulatory responsibilities related packaging development
* Ensure the local label creation and packaging development will meet local and corporate criteria and supports the business needs
c) Metrics Review
i) Prepare periodic Regulatory Report of actual submissions and approval
3. Regulatory Compliance
a) Compliance Maintenance
i) Take appropriate actions to maintain all local marketed products in compliance with local and corporate regulatory requirements [eg. all aspects of labeling (Product Information and packaging development); label change management; chemistry and manufacturing commitments that are registered with the DRA]
ii) Conduct periodic compliance self-audit to identify potential compliance issues
iii) Perform activities related to pharmacovigilance (PhV) according to Corporate and if applicable, by local regulations.
iv) Take corrective actions plans based on regulatory audit findings
b) Good Regulatory Practices (GRP)
i) Develop, update and implement appropriate SOPs as required by the Global Regulatory Affairs policies (Regulatory Quality Systems), local regulations and acceptable Good Regulatory Practices.
ii) Complete Global Regulatory Core Curriculum and Good Regulatory Practices training
4. Regulatory Influence
a) Regulatory Customer Relations
Establish relationship with key regulatory officials to influence regulators to
influence regulators to foster positive regulatory environment for business and research.
b) Regulatory Environment Changes
Keep updated with current local regulations and DRA organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or affected parties.
c) Influence Strategy
Supports the development and implementation of the established external regulatory influence strategy.
a) Affiliate Organization
i) Learn and understand the local affiliate organization and functions.
ii) Build functional partnership and credibility to maximize regulatory value in support of business decisions.
5. Additional Responsibilities
Responsible for preparation and submission of license pertaining to Legal Metrology, BIS, DPCO for all technical documents for the application of storage license for new wholesale license, if any.
The Successful Applicant
Minimum 4 years of regulatory affairs experience with excellent understanding in Medical Device Domain In-depth knowledge of local regulations pertaining to product registration requirements for Medical Device, Pharmaceutical products and understand its interpretation.
What's on Offer
An opportunity to work with an organisation known in the industry for handsome career progression and rewards with an inspirational leadership.