What are the responsibilities and job description for the Regulatory Affairs Specialist II position at Planet Pharma?
Regulatory Affairs Specialist II - APAC
Location : Alameda, CA (Onsite only)
Contract Duration : 12 months (with possible extension)
Pay Rate : $40 56 / hr. (depending on experience)
Top 3 Requirements :
- Direct Regulatory Submissions Experience : Candidates must have hands-on experience with regulatory submissions . Experience in regulatory affairs is necessary, but experience writing and managing submissions is essential.
- APAC Regulatory Experience : Candidates should have specific regulatory experience within the APAC region . A strong understanding of APAC regulations (e.
g., TGA, NMPA, PMDA) is highly preferred.
Relevant Regulatory Experience : We are looking for candidates with direct and relevant regulatory affairs experience .
Position Overview :
We are seeking a Regulatory Affairs Specialist II with APAC regulatory submissions experience, preferably within the medical device or pharmaceutical industry.
This individual will work onsite at our Alameda, CA office to support regulatory activities in APAC regions, including Australia, China, Japan, Korea, and Southeast Asia.
The ideal candidate should be highly detail-oriented, with more than 5 years of relevant experience, specifically in regulatory submissions , product registrations, and regulatory impact assessments.
The role will not require direct interaction with local health authorities; however, the specialist will closely collaborate with internal teams to ensure compliance with country-specific regulations and manage regulatory submissions from start to finish.
Key Responsibilities :
- Manage regulatory activities, including product registrations and regulatory impact assessments for APAC markets.
- Ensure that all regulatory submissions align with APAC-specific requirements (TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.).
- Communicate regularly with affiliate RAs across multiple time zones to align on ongoing projects and resolve issues.
- Work closely with internal teams, including product management , engineering , and labeling , to gather necessary information for submission and ensure timely execution.
- Provide regulatory guidance to cross-functional teams and interpret applicable regulations during product development and post-market activities.
- Proactively plan, execute, and report on tasks to ensure compliance and smooth submission processes.
- Ensure all training records are kept up-to-date and meet internal regulatory requirements.
- Initiate projects immediately after completing required internal system training.
Required Skills and Qualifications :
- 5 years of regulatory experience with a focus on APAC regulatory submissions in the medical device or pharmaceutical industries.
- Strong understanding of international standards, such as ISO 13485 and IEC 60601 , and APAC country regulations (TGA, NMPA, PMDA, etc.).
- Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Microbiology, Immunology, Medical Technology, etc.).
- Experience with regulatory documentation , labeling , and change control processes.
- Familiarity with Agile methodologies , SharePoint , MS Office , and other tools to improve efficiency.
- Able to work independently with minimal supervision and proactively manage projects and time.
- Strong communication skills to work effectively with stakeholders in different time zones.
- Must be able to commit to a full 40-hour workweek .
Desirable Skills :
- Knowledge of regulatory activities related to IVDs (In Vitro Diagnostics) and biologics .
- Experience in pre-market and post-market regulatory affairs within the medical device industry.
- Strong attention to detail and the ability to analyze how changes in regulations may impact the submission process.
Job Requirements :
- Must be located locally (no relocation considered at this time).
- 100% onsite role in Alameda, CA (no hybrid or remote flexibility).
- Flexibility to accommodate occasional later calls with teams in different time zones to manage regulatory tasks across APAC regions.
Interview Process :
- Initial video interview with the hiring manager.
- Second-round interview may be scheduled if needed after the first call, based on the candidate’s performance.
Salary : $40
