Regulatory Affairs Specialist

Regulatory Affairs Specialist
1 year contract, potential to renew

Come and join us!
Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing?

“FIND YOUR PLACE” by joining a world-class MNC Healthcare company
Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.

Company Description:
Our client is an MNC Healthcare company. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, they are empowered to tackle the world’s toughest health challenges, innovate through science and technology, and transform patient care.

General Description
The Regulatory Affairs Specialist MedTech is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices and pharmaceutical products under their responsibility. The position is responsible for providing input into the global regulatory strategy and identifying country requirements for successful regulatory filings for new products/indications and line extensions.

The Regulatory Affairs Specialist MedTech will be a member of the local regulatory affairs department within organization Medical, with responsibility to support the regulatory aspects of the assigned product portfolio/s

Key responsibilities:

• Preparation of submissions to the local health authority for new products, license renewals, and variations to existing products in line with Marketing launch plans, with guidance from senior regulatory colleagues as necessary
• Maintain departmental and source company databases of regulatory approvals
• Complete copy and labeling review as required
• Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of local regulatory requirements and request the documentation required for registration submissions
• Build constructive relationships with the local health authority and executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status.
• Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio
• Contribute to continuous review and improvement of processes within the Country Regulatory Affairs (RA) department to ensure consistent, efficient and effective practices
• Engage Marketing colleagues to strategize new product regulatory pathways, line extensions and changes to currently approved products and actively accelerate launch timelines.
• Leverages a solid working knowledge of the global regulatory environment, including proposed laws, regulations

Required Qualification and Core Competencies for the role:

• Bachelor's degree or equivalent in Biomedical Engineering / Biomedical Sciences / Life Sciences / Pharmacy / related discipline with minimum 1 year of experience
• Previous experience in preparing documents for health authority submissions (Clinical Trial Application, Chemistry & Manufacturing, and or Registration dossiers) is desirable;
• Ability to interpret complex issues and technologies and present them in simple terms to facilitate understanding by others;
• Demonstrated ability to handle multiple projects;

Interested parties, please apply through this link https://jnj-apac.talent pool.com/projects OR click on APPLY button. Alternatively, you can share your CV at [email protected]

EA License: 94C3609
Reg No: R1440247