Johnson & Johnson
Regulatory Affairs Specialist
Regulatory Affairs Specialist
1 year contract with 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 our client Johnson & Johnson
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.
Johnson & Johnson WORKSENSETM (via Randstad Sourceright) is responsible for finding, engaging, and contracting talent for the Johnson & Johnson contingent workforce.
About Johnson & Johnson
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people.
As an equal opportunity employer Johnson & Johnson value diversity at their company. They don’t discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
- Assist the RA (Regulatory Affairs) manager to compile and submit new drug applications, new indication submission as well as variation submissions.
- Ensure compliance to company SOP and Quality Management System.
- Ensure timely product registration by internal timelines
- Prepares and maintain existing product licenses with updated changes
- Gathers and assemblesinformation necessary for submission in accordance with regulations and relevant guidelines
- Prepares responses to regulatory agencies’ questions and other correspondences, in collaboration with local and global functional teams
- Assist RA Managerto Interact with regulatory agencypersonnel in order to expediteapproval of pending application and to resolve regulatory matters
- Assist RA manager to collaborate with internal stakeholders (eg. Medical Affairs, Marketing) to manage product strategy, local registration and launch activities. Align filing plans and timelines with internal stakeholders e.g., business partners and regional office.
- Ensure adherence to standard operating procedures and protocol for the timely approval of marketed drugs
- Ensure compliance to J&J and local regulatory guidelines
- Provide ad-hoc local assessment on regulatory filings
- Manage and maintain local and global regulatory tracking systems
- Ensure post-approval commitments by the health authority are managed in a compliant manner
- Bachelor's degree or equivalent in Science, Pharmacy or related discipline;
- Experience with Pharm RA submission to HSA is required
- Proactive team player, able to take charge and follow-through;
- Proficiency with Microsoft applications such as Excel, Word, Powerpoint.
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@example.com
EA License: 94C3609
Reg No: R1440247