Process Lead - QA/RA

Job Description

Review RA files (New registration, Variation, Renewal, Inquiry response as per updated guideline).
Perform review of all quality related documents, including but not limited to (MFM, FPD, CCF, ECT)
Coordinate and respectively prepare timely letters to support registration activities & license maintenance consistent with the agreed HA letters strategy.
Vendor per Country list: Maintain timely manner update of Vendor per country list as per HAs approval for registration or variation, etc.
Setup system for tracking of regulatory files/communication review and approval for submissions.
Vendor per Country list: Daily Timely manner update of Vendor per country list as per distribution emails related to HAs approval for registration or variation, ect. Periodical posting on Julphar intranet on quarterly basis. Update tracker & list relocation in time.
Support in following Circular assessment by concerned stakeholders & ensure its Proper assessments, update tracker& Circular Notification relocation in time.
Oversight all PV related activities for RAK global PV, including but not limited to PSURs, PSMF, ICSRs, RMPs, and RMMs.
Quality Technical File preparation upon MOHAP request as per approved quality standards.
TenderBD questionnaire fulfillment by collecting all relative documents from all concerned stakeholders & compiling for submission.
Support & address issues related to regulatory compliance checks.
Solve complex CMC issues related to the product.
Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide consultation as a scientific/technical resource for raised changes and projects, mentor and share experience with colleagues.
Act as QA oversight personnel for PV system including quality review and approvals for the relevant documents and HA communications.
Oversight all PV related activities for RAK global PV.
Provide regulatory support in view of current Health authority regulatory intelligence information.
Support local training to build regulatory knowledge as needed to support regulatory compliance at site level
Support maintenance of effective processes within area of responsibility
Core Competency
In terms of competency you are highly result oriented with strong sense of accountability & ownership.
Solid Technical knowledge with strong implantation skills
High on communication and collaboration, having an ability to manage multiple stakeholders at a time
Must have organizational skills, and planning with proactive oriented attitude in project management.
In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping
Must be able to manage tasks and priorities and easily adapt to changing situations.
Strong communication, interpersonal and negotiation skills as well as capability to influence others in a matrix organization.
Ability to create cross functional relations and manage conflicts.
Problem Solving and high agility on taking right decisions
Qualifications:
- Education
4 years Bachelor degree in Pharmacy/ Life Sciences /any discipline in same field.
Master degree in Quality Management is a plus.
- Experience:
Total 6 - 8 years of experience pharmaceutical industry preferably in Quality Management systems. And proven experience in Regulatory or pharmacovigilance and distributor management as well.
Should have handled similar role for better fitment.
- Training:
Key Competencies:
Excellent command in English (Communicating, writing and speaking).
Proficient in MS Microsoft office and computer knowledge.