Job Description
About Company
Similar Jobs
Please verify your account first!
Send OTP
Please click on the Apply to verify the status of jobs posted more than 15 days ago, as they may have expired. Similar Jobs
Job Description
The primary purpose of this role is to maintain awareness of local and regional regulatory requirements through monitoring, analysis and interpretation to support both compliance and regional regulatory policy priorities.
Delivery of consolidated regulatory/PV regulatory intelligence in accordance with company expectations.
Regulatory/PV Regulatory Impact Assessment & Stakeholder Engagement
Experience Level: 5 to 8 years
- The Regulatory Intelligence Senior Associate is responsible for:
- Contributing to the delivery of regulatory intelligence and pharmacovigilance (PV) regulatory intelligence tailored to CLIENT priorities.
- Engaging with Global Regulatory Affairs & Safety (GRAS) staff, including affiliate-based Local Regulatory Representatives (LRRs) and Local Safety Officers (LSOs) and Regional Regulatory Leads (RRLs) and Regional Safety Officers (RSOs) as required.
- Monitoring and analysis of regulatory and PV regulatory safety updates (new and revised laws and regulatory information issued by health authorities) to support internal impact assessments.
- Management of impact assessment of new/revised regulatory and PV regulatory information, including engaging with local and global subject matter experts (SMEs) in accordance with company SOPs.
- Providing intelligence analysis and policy support tailored to CLIENT internal priorities, including preliminary analysis of potential impacts for CLIENT.
- Other tasks that may be assigned from time to time.
- The role is expected to work in coordination with similar roles in other regulatory jurisdictions, such that regulatory intelligence and PV regulatory intelligence activities are coordinated across the geographies in which CLIENT operates.
- The role reports to the Global Regulatory and Safety Policy & Intelligence (GRASP) team.
Delivery of consolidated regulatory/PV regulatory intelligence in accordance with company expectations.
Regulatory/PV Regulatory Impact Assessment & Stakeholder Engagement
- Monitoring and analysis of regulatory updates (including laws, guidelines, technical requirements, and trends) issued by relevant regulatory bodies in the territory
- In conjunction with local GRAS SMEs, provide a local assessment/interpretation of new/revised regulatory information and triage for global impact assessment according to company SOPs
- Manage global impact assessments of new/revised regulatory information according to company SOPs
- In conjunction with local PV SMEs, provide a local assessment/interpretation of new/revised PV regulatory intelligence and triage for a global impact assessment according to company SOPs
- Provide intelligence analyses and support for regulatory policy priorities (e.g., major legislative changes with direct impact on CLIENT)
- Track regulatory policy updates and trends issued by relevant legislative and regulatory bodies
- Provide strategic input to company SMEs by curating impact assessments, including evaluating potential impacts on technical and procedural requirements and translating these into actionable insights
- Support policy activities by providing preliminary analysis of regulatory challenges and opportunities and insights on how to mitigate risks or capitalise on opportunities
- Provide analyses according to company processes and using company templates.
- Liaise with local and global GRAS SMEs, clinical, medical affairs, and quality assurance SMEs as required to ensure alignment on impact assessment activities
- Advise internal regulatory teams and GRASP Regional Leads on evolving regulatory expectations
- Ensure alignment between country-specific regulatory intelligence and the companys global regulatory intelligence/impact assessment framework.
- Maintain structured regulatory intelligence tracking to ensure timely awareness of emerging regulatory signals
- Contribute to the development and maintenance of regulatory intelligence databases, trackers, and internal communication channels
- Ensure all regulatory intelligence activities adhere to the companys internal governance policies and compliance standards
- Support the preparation and conduct of pharmacovigilance (PV) inspections and audits, as requested.
Looking to get Placed? Try our Placement Guarantee Plan
- In-depth understanding of the APAC pharmaceutical regulatory environment, including policy reform trends, approval pathways, and lifecycle management requirements.
- Exceptional organizational skills to manage multiple tracking systems, prioritize information, and ensure timely delivery of intelligence outputs
- Proven capability to coordinate cross-culturally across time zones and geographic locations, fostering collaboration between global and local teams.
- Adaptable communication for diverse stakeholders (local and global SMEs)
Experience Level: 5 to 8 years
Skills
Senior AssociateIf an employer asks you to pay any kind of fee, please notify us immediately. Jobaaj does not charge any fee from the applicants and we do not allow other companies also to do so.
About Company
Parexel is a global biopharmaceutical services company. More detailed description requires accessing their website.
Important dates & deadlines?
Application Deadline
21 Jun 26, 06:26 PM IST
Similar Jobs
View All
Loading...
Don't Miss out any Updates
Subscribe now for the latest job alerts
and never miss an update
Job Alert
Google hiring for Specific Roles Apply Now!
1 min ago
New Opportunity
Amazon is hiring freshers Apply Now!
5 min ago
Featured Jobs
Microsoft opening 50+ positions Apply Now!
10 min ago
