Senior Associate
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Job Location:
Monthly Salary:
Posted on:
23 hours ago
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
1 Contribute to delivery of regulatory intelligence and pharmacovigilance (PV) regulatory intelligence for Mainland China and Taiwan.
- Deliver consolidated regulatory intelligence for Mainland China and Taiwan in accordance with company expectations.
2 Regulatory/PV Regulatory Impact Assessment & Stakeholder Engagement
- Monitoring and analysis of regulatory updates (including laws guidelines technical requirements and trends) issued by the NMPA CDE TFDA and other relevant regulatory bodies in Mainland China and Taiwan
- In conjunction with local GRAS SMEs provide a local assessment/interpretation of new/revised regulatory information and triage for a global impact assessment according to company SOPs
- Manage global impact assessments of new/revised regulatory information for Mainland China and Taiwan 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 SOP.
3 Regulatory Policy: Intelligence Analysis & Support
- Provide intelligence analyses and support for regulatory policy priorities (e.g. major legislative changes with direct impact on CSL).
- Track regulatory policy updates trends issued by the NMPA CDE and other relevant regulatory bodies in Mainland China and Taiwan.
- 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.
Maintain structured regulatory intelligence tracking to ensure timely awareness of emerging regulatory signals.
4 Global-Local Regulatory Alignment & Liaison
- Liaise with local and global GRAS teams/SMEs clinical medical affairs and quality assurance SMEs to ensure alignment on impact assessment activities.
- Advise internal regulatory teams and GRASP Regional Lead on evolving regulatory expectations.
- Ensure alignment between country-specific regulatory intelligence and the companys global regulatory intelligence/impact assessment framework.
5 Regulatory Intelligence Infrastructure Management
- Develop maintain and optimize 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 PV inspections and audits as requested.
Required Experience:
Senior IC
Key Skills
- Business Development
- Organizational Management
- GAAP
- Accounting
- Analysis Skills
- Meeting Facilitation
- Microsoft Powerpoint
- Investment Banking
- Microsoft Excel
- Private equity
- Financial Modeling
- Writing Skills
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
