Johnson & Johnson is currently seeking a Regulatory Affairs Specialist to join our Regulatory Affairs team located in Singapore.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
POSITION SUMMARY:
The Regulatory Affairs Specialist is a member of the Local Operating Company (LOC) Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life cycle management submissions are under the scope of the Regulatory Management Centre (RMC), and this Regulatory Affairs Specialist is responsible for exclusively managing RMC submissions, whilst being part of the overall regulatory team in the LOC and support ad-hoc LOC regulatory activities where applicable. The position reports to the LOC Regulatory Affairs Lead.
RESPONSIBILITIES:

• Receive CLCN and CMC variations from the AP RMC and identify if submission to the local Health Authority is required.
• Assess dossier for impact to country registration.
• Provide details on submission strategy to the AP RMC to ensure timely updating of compliance tracking systems.
• Prepare submission dossier based on global dispatch and country specific requirements.
• Request country specific documents for submission, such as data administration, translation, artwork, samples and certificate.
• Work with the RMC Liaison who will be the single point of contact with global teams, to resolve any issues with the submission package from global.
• Ensure country specific requirements are accurately maintained in CLRR or equivalent system.
• Receive HA queries and send to the RMC Liaison assigned to the product portfolio for management.
• Communicate submission and approval dates of life cycle management submissions to the RMC Liaison.
• Complete any post-approval activities required for a life cycle management submission.
• Participate in team meetings, activities, and trainings as a full member of the LOC Regulatory Affairs team.
• Communicate local regulation changes in a timely manner to the RMC Liaison who has been assigned as the country/cluster partner.
• Assist LOC Regulatory Affairs team to prepare new drug applications, new indication and local-initiated submissions as well as support ad-hoc local regulatory affairs activities, where applicable.

Qualifications

Required

• University degree in pharmacy, life sciences or equivalent field
• 2 years or more relevant work experience in Regulatory Affairs(RA)/Government Affairs/Quality/Compliance/Manufacturing in medical or pharmaceutical companies
• Previous experience in RA role as Associate, Professional or similar role is of advantage.
• Proficient in English (including technical RA English)
• Experience of working in a virtual team and/or global organization.
• Knowledge of local regulations and international standards.
• Able to make independent decisions.
• Able to analyze (complex) information and situations to formulate clear solutions.
• Good communication and team collaboration skills required.

Desirable

• Project management: build and lead project teams, get things done, drive execution, collaborate in virtual teams.
• Detail-orientation combined with ability to understand issues from a big-picture perspective.
• Analytical skills and technical RA knowledge (ability to assess impact of CMC variation or Label change on current situation)
• Ability to quickly acquire local knowledge and shift between local situations.
• Communication skills and cultural sensitivity in working with stakeholders across countries.
• Team player able to effectively collaborate with colleagues in a virtual environment and perform efficient handovers.