Regulatory Affairs Associate– Singapore
Medical Devices & Diagnostics
Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company,
touching the lives of nearly a billion people every day. Our Family of Companies throughout the world
compete in consumer, pharmaceutical and medical devices and diagnostics markets and have the skills
and resources to tackle the world's most pressing health issues.
Job Description
The Regulatory Affairs (RA) Associate will be a member of the local regulatory affairs department within
Johnson & Johnson Medical, Singapore, with responsibility for regulatory aspects of the assigned
product portfolio/s in as follows:
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Preparation of submissions to HSA for new products and variations to existing products in
line with Marketing launch plans with guidance from senior regulatory colleagues as
necessary.
Undertake SAP training and ensure that current and correct regulatory information is
entered into SAP for all products codes within the assigned portfolio.
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 regulatory requirements in Singapore and request the
documentation required for registration submissions.
Build constructive relationships with HSA by compiling and submitting high quality
submissions and providing prompt responses to questions.
Review and comment on proposed new legislation and/or HSA policies and guidelines as
part of the consultative review process.
Contribute to continuous review and improvement of processes within RA to ensure
consistent, efficient and effective practices across the team.
Participate in discussion groups for the industry association, as required
Contribute to RA Team meetings to learn from colleagues, share experiences and best
practice.
Assist colleagues in supporting other business units or product portfolios
Take responsibility for coordinating the release for supply of unapproved medical devices
under the Special Access Scheme (SAS)
Establish meetings with Marketing colleagues to share information about new products, line
extensions and changes to currently approved products and review timelines for HSA
approvals.
Develop knowledge of laws and regulations applying to local and international applications
This position reports to the ASEAN RA Manager.
Required
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Minimum bachelor's degree or equivalent in Pharmacy.
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Must be a registered Pharmacist with the Singapore Pharmacy Board
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Desired
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Familiarity with the Singapore regulatory systems and product registration requirements.
Minimum 3 years of working experience in a related field (pharmacy, regulatory affairs,
clinical research)
Excellent verbal and written communication skills - proficiency in written and oral English is
required.
Ability to interpret complex issues and technologies and present them in simple terms to
facilitate understanding by others.
Demonstrated ability to handle multiple projects.
Must be able to develop and maintain excellent working relationships, work successfully
within a team environment and as an individual contributor.
Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as
an ability to work in a matrix environment are required
Enthusiasm for Regulatory Affairs: achievement-oriented with a high degree of flexibility and
ability to adapt to a changing regulatory environment.
Proactive team player, able to take charge and follow-through.
Previous experience in preparing documents for health authority submissions (Clinical Trial
Application, Chemistry & Manufacturing, and or Registration dossiers) is desirable.
Location
Position location is Singapore with occasional travel. There is no relocation support.
To Apply
Do you meet the requirements of this position and are interested in building a career with Johnson &
Johnson? Go to www.careers.jnj.com, select the appropriate fields under “Search Jobs” and apply using
requisition number 8473110929 by 14th October 2011. All applications must come through the portal.