Regulatory Affairs Manager, APAC
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Singapore • Singapore
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About the role
- Provides direction for the activities related with assigned products
- Works with regional management, head office-based team members and local operating companies to define and implement the regional and local strategy for assigned products
- Responsible for the development of the regional regulatory strategy and ensures the implementation of multi-national/regional regulatory and strategies
- Understands regional and local requirements and advises the Global Regulatory Team (GRT) on applicable regulatory requirements, guidelines and processes
- Participates as a standing member of the project related GRT
- Expedites commercialization of new products, new indications and line extension via participation in the AP Compound teams
- Provides guidance to local affiliates on development of strategies to accelerate submissions/approvals
- Manages regulatory interactions with local operating companies
- Acts as the primary contact with multifunctional regional teams
- Provides input to submission tactical planning and timelines including lifecycle submissions
- Ensures tracking of submission and approval milestones
Requirements
- Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline
- Minimum of 8+ years of overall experience (5+ years relevant pharmaceutical industry and regulatory experience) OR Masters/PharmD and 6+ years; PhD and 4+ years
- Hands’ on experience in pharmaceutical product registration in AP countries
- Familiarity with AP regulatory systems and product registration requirements, preferably relevant experience in the oncology therapeutic area
- Previous experience in preparing documents for health authority submissions (Clinical Trial Application, Chemistry & Manufacturing, and/or Registration dossiers)
- Ability to communicate to senior level management
- Cultural sensitivity and ability to work and thrive in a multi-cultural environment
- Proactive team player, able to take charge and follow-through
- Proficient use of technology including MS office programs and Internet resources
- Must be able to work flexible hours to accommodate early morning/evening meetings/teleconferences with different time zones.
Benefits
- Inclusive work environment
- Opportunities for professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmaceutical product registrationregulatory strategy developmentsubmission tactical planninglifecycle submissionshealth authority submissionsClinical Trial ApplicationChemistry & ManufacturingRegistration dossiersoncology therapeutic arearegulatory requirements
Soft Skills
communication to senior managementcultural sensitivityteam playerproactiveability to work in a multi-cultural environmentleadershiporganizational skillsflexibilityfollow-throughcollaboration
Certifications
Bachelor's degree in pharmacyBachelor's degree in life-scienceBachelor's degree in health-related disciplineMaster's degreePharmDPhD