Regional Submission Coordinator - Regulatory RIM support - Malaysia
JOB SUMMARY
Location: Petaling Jaya, Selangor, Malaysia
Category: Research & Development
Job Type Full Time Regular
Job Id: R-51094
About Lilly
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana.
HOW TO WRITE GOOD JOB RESUME/ CURRICULUM VITAE (CV)
Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Primary Responsibilities:
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
> Build high level of technical expertise (RIM) and contribute to process improvement initiatives
* Stay up to date on system upgrades and ensure continuous buildup of technical and practical proficiency with Veeva Vault RIM.
* Support process and system improvement initiatives.
* Participate in the evaluation of new opportunities for centralizing/regionalizing tasks.
* Participate in supporting activities/projects regarding submissions.
> RIM Content Planning
* Support Affiliate Regulatory/Alliance Managers with RIM content planning for all submission types.
* Match appropriate documents to the RIM content plan, send content plan for review and when review complete, lock & confirm the top-level content plan.
* Send notification for export to Affiliate Regulatory/Alliance Managers and/or eCTD publisher.
> Post Approval Submission Coordination
* Execute the operational aspects of the post approval submission agenda for all products in assigned countries/regions, monitoring post approval submission plans to achieve planned submission date.
* Collaborate with Lilly Affiliate Regulatory and Alliance Managers/Associates and directly interact with external alliance business partners and liaise with cross-functional partners.
* Create RAPT/RIM Renewal and Manufacturing Site Registration/Renewal records and maintain planned/target/actual submission and approval dates for all post approval activities in collaboration with the Affiliate/Alliance Manager. When creating Renewal and Manufacturing Site Registration/Renewal records, obtain confirmation from Affiliate/Alliance Managers.
* Periodically inform the external business alliance partner of planned/upcoming submissions.
* Complete or support completion of ACRR form.
* Clarify requirements by liaising with various support groups for efficient submission activities.
* Track support status and ensure on time availability by early support planning and follow up with support providers.
* For products for which Lilly holds the license, evaluate received documentation or obtain evaluation outcome from business alliance partner & follow-up on amendments to meet requirements.
* For products for which Lilly holds the license, prepare/draft module 1 documents in alignment with affiliate regulatory.
* Match appropriate documents to the RIM content plan, send content plan for review and when review complete, lock & confirm the top-level content plan.
* Send notification for export to Affiliate Regulatory and/or eCTD publisher. For products for which the external business alliance partner holds the license, export the content plan, send to the partner for submission, and confirm with the partner the requirement to submit the complete package.
* For products for which an external alliance business partner holds the license, perform archiving activities (e.g., submitted dossier, incoming Health Authority correspondence) as described in the contract.
* Record and archive incoming Health Authority questions & send to response owner.
* Support technical compilation of responses.Escalate issues that may impact submissions and timelines.
> Affiliate regulatory RIM system support:
* Support training for affiliate regulatory on the RIM system and associated business processes for regulatory submissions and registration management.
* Support affiliate personnel with resolving process issues or execution of processes in the RIM system.
* Assist with monitoring appropriate metrics to ensure data quality in the system.
* Lead/support the implementation of system improvements through communication and training across the affiliates.
> Personal and Professional Development
* Build and maintain knowledge and understanding of local and if appropriate regional regulations and submission requirements for countries of responsibility and other submission elements, as needed.
* Manage own performance and development by actively setting and meeting individual professional development goals.
Minimum Qualification Requirements:
> Bachelor’s degree and 5 years of experience in regulatory.
> Experience in, and/or leading different groups in regulatory.
> Demonstrated ability to implement strategies and plans to improve complex processes.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs.
If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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