GRCY-0, Regional Regulatory Affairs Senior Associate

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

Your Role:

• Executes all regulatory submissions in the assigned APAC countries per regulatory and business requirements, for both product and clinical trial applications
• Supports regional/local and global strategies, plans, and communicates registration and plans and generates options to obtain product approvals and supports product changes.
• Ensures ready to submit dossier is available as per respective countries requirements through timely dossier compilation.
• Coordinates labeling compliance and support promotional material process.
• Ensures regulatory activities for the assigned Asian countries and portfolio are tracked irrelevant company systems according to compliant procedures.
• Participates in business meetings with cross-functional teams & external customers and provide active and ongoing guidance within submission projects.
• Assists Global Regulatory Affairs department in the update, enhancement & creation of internal procedures.
• Reviews and assesses health authority regulations and competitor intelligence across Asia.
• Able to travel as per business need.

As Regional Product Lead

A) Project Development:

• Performs pipeline monitoring & program/project development.
• Collects data for RA Strategy for new CTA, MAA and LCM
• Provides support for Early Access Program (EAP) / Named Patient Sales (NPS)
• Ensures effective communication across RA (top-down and bottom-up) and knowledge sharing about Pipeline/Portfolio
• Attends product specific GRST/IRST

B) Strategy Alignment

• Validates requirements for the strategy development & contributes to new projects roll-out strategy.
• Acts as regional RA representative at regional cross-functional interactions/meetings and follow up on BC preparation and projects.
• Coordinates filing of template for cross-functional alignment and country requirements check-list as per TA for new project.
• Aligns with POC/CRA on regulatory strategy.

C) Dossier Readiness

• For non-zero-based countries
• Oversees availability of the dossier related to LCM and new CTA, MAA by coordinating with REC/GRA/CRA/POC (provides preventive actions if needed)
• Supports in dossier preparations as requested by CRA.

• For zero-based countries
• Attends, participates and acts on agreements on the strategy submission and timelines for all submissions.
• Ensures availability of dossier for all submissions by collaborating with REC/GRA/POC (provides preventive actions if needed

D) Application Submission

• Ensures timely submission/dispatch of the dossier related to LCM and new CTA, MAA by collaborating with REC/GRA/CRA/POC and timely Veeva Vault updates

E)  Application Approval

• Follows up on approval status of LCM and new CTA, MAA in APAC region and shares regular update with Global and regional cross-functional team.
• Ensures timely ATO preparation, submission/dispatch for LCM and new, CTAMAA by collaborating with PPD/REC/GRA/CRA/POC and updates Veeva Vault in timely manner.

F) Product Maintenance

• Ensures effective communication across RA (top-down and bottom-up)
• Acts as regional support for CRA/POC for timely RA assessment/ dossier preparation/ submission / approval.
• Acts as regional RA representative at regional cross-functional interactions/meetings and contribution from RA perspective.
• Supports Regional TA Coordinator in crisis & coordination/ overseeing crisis management process.
• Ensures timely escalation of RA challenges to Regional TA Coordinator and Regional RA Head

Country Point of Contact (PoC) / Sub PoC

 A) Project Development

• Ensures pipeline monitoring & program/project development in coordination with RPL.
• Manages Early Access Program (EAP) / Named Patient Sales (NPS) in the country in coordination with the RPL.

B) Strategy Alignment

• Validates country requirements for the strategy development and contribution onto new projects roll out strategy.
• Provides RA strategy on commercial business case.
• Provides inputs of country requirements for new project

C) Dossier Readiness

• Attends, participates, and acts on KOM agreements of the strategy submission and timelines for major LCM and new CTA, MAA.

D) Application Submission

• For zero-based countries, ensures timely submission of the dossier by cooperation with RPL.
• Engages with country HA.

E) Application Approval

• For zero-based countries, receives and communicates the approval status from HA to RPL and RAA

F) Product Maintenance

• Provides country intelligence to RPL in performing regulatory assessments and dossier preparation.
• Ensures timely escalation of product specific country regulatory challenges to RPL.

G) Stakeholder Management

• Coordinates with local stakeholders
• Manages country specific activities (e.g., Audit, Change Control, Promotional Material Review, Special Permit, Packaging Materials, Tender, HA Inspections, Import License)
• Participates in HA and Industry meetings.
• Manages external consultant and business partners, when applicable

Who You Are:

• Degree or higher degree in Life Science, Pharmacy or related discipline
• Excellent verbal and written English Skills.
• Minimum of 3 years of regulatory experience in Pharmaceutical Product Registration and Clinical Trial application.
• Demonstrated in- depth experience with preparation of regulatory documentation to support product and trial applications, as well as agency interactions. (FDA)
• Thorough knowledge of NDA, CTA/ CTD requirements. – Clinical Trial application / Common Technical Documents, New Drug Application
• Working knowledge in global organization with strong collaboration and stakeholder management skills, including cross functional
• Experience with regulatory authorization in at least one of APAC country

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!