Senior RA Manager, APAC (Pharma)
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Job Location:
Monthly Salary:
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
MAIN PURPOSE OF ROLE
The APAC senior regulatory manager supports the APAC RA Director in the daily activities related to product registration tracking and lifecycle maintenance.
This position ensures that product registrations across APAC countries are progressing according to timelines and supports regulatory compliance throughout the region.
A key responsibility includes monitoring and supporting execution for biosimilar registration plans providing support and coordination to local RA teams as needed.
In addition the position leads and executes various region-level projects and consolidations including but not limited to:
Label Sanity Check Project (Project Label Guard)
SIR (Status Information Report) / RP (Registered Position) Improvement Project
Generics (Gx) / Competitor Monitoring
Other ad-hoc surveys and consolidations
MAIN RESPONSIBILITIES
1. Product registrations /Submissions
Coordinates the execution of the regulatory strategies ensuring close monitoring and follow up with the affiliates and timely reporting to the APAC RA Director.
2. Relationships & Cross Functional teamwork
- Ensures good collaboration and relationships with the regulatory teams in the affiliate and the emerging markets.
- Supports the internal stakeholders for any regulatory affairs ad-hoc request.
3. Affiliate Coordination
Maintains effective working relationships with local RA teams.
Ensures proper coordination between the RA affiliates and stakeholders in the defined areas.
4. Compliance across lifecycles
Supports the coordination of new product registration activities ensuring alignment with regulatory requirements and business timelines.
Provides daytoday support to ensure products remain compliant throughout their lifecycle.
5. Strategy
Assists APAC affiliates with the execution of regulatory plans that align with regional business priorities.
Supports the implementation of agreed regulatory strategies and helps monitor updates to ensure continued alignment with evolving regulatory and business needs.
Contributes to project teams by providing regulatory input helping address routine issues and supporting the Head of RA affiliates in APAC in guiding assigned activities
6. Regulatory Operations
Coordinates the preparation and submission of registration dossiers variations renewals and clinical trial applications ensuring timely execution in collaboration with APAC affiliates
Monitors timelines for key submissions (e.g. new registrations variations CCDS updates PSURs license renewals) and supports affiliates to ensure continuity of product availability.
QUALIFICATIONS
Education
Bachelors Degree of Pharmacy or Bachelors Degree of Life Science or Bachelors Degree of Science
Experience / Background
At least 5-7 years of working experience in similar roles (TH local and/or APAC regional roles).
Understanding of regulatory affairs in pharmaceutical environment experience interfacing with government and regulatory agencies and proven skills in developing and implementing successful regulatory strategies. Strong communication skills to effectively present regulatory information to management and government agencies
Management Skills
Uses resources effectively and efficiently.
Able to plan prioritize and delegate tasks to project team as needed to ensure timely completion of projects.
Maintain and operate within budget.
Capable of analyzing and investigating issues and problem solving.
Communication Skills
Effectively practices listening skills before responding to issues.
Effectively writes presents and communicates information to internal and external clients including divisional management.
Effective negotiation skills.
Total Quality Management (TQM) Skills
Demonstrates the ability to exercise good judgment on regulatory and compliance issues.
Demonstrates an understanding of the appropriate regulatory requirements and applies this understanding to all job responsibilities.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
Thailand > Bangkok : Q-House Lumpini Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 25 % of the Time
MEDICAL SURVEILLANCE:
Yes
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Required Experience:
Manager
Key Skills
- Program Management
- FDA Regulations
- Management Experience
- Facilities Management
- Clinical Development
- Data Management
- Quality Systems
- Project Management
- Research & Development
- GLP
- Budgeting
- Leadership Experience
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
