Johnson & Johnson
Regulatory Affairs Specialist
Regulatory Submissions Specialist
1 year contract, potential to renew or convert
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.
The Regulatory Submissions 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 Submissions 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 Manager.
· Receive 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 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, EXPERIENCE AND COMPETENCIES
· Degree in pharmacy, life sciences or equivalent field with 2-4 years of 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.
· 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.
· 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.
· Team player able to effectively collaborate with colleagues in a virtual environment and perform efficient handovers.
Applicants must be fully vaccinated or have a valid exemption in accordance with MOM’s regulations to allow them to enter the workplace. Applicants may be required to share verifiable COVID-19 vaccination documents or proof of a valid exemption at the point of offer. Randstad Pte. Limited and/or the Client reserves the right to withdraw an offer if the applicant fails to provide verifiable COVID-19 vaccination and/or proof of exemption documents.
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 firstname.lastname@example.org
EA License: 94C3609
Reg No: R1440247