North Africa Alliance Regulatory Associate At Lilly Egypt
Title North Africa Alliance Regulatory Associate
State / Province Cairo
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. Our 35,000 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.
North Africa Regulatory Alliance Associate (P1/P2)
The purpose of the North Africa Regulatory Alliance Associate role is to manage the operational and technical aspects of regulatory support on Lilly’s behalf for the strategic business partners who are Marketing Authorisation Holders for Lilly products in the North Africa region, including:
Partner Oversight: Align on submission plans, monitor progress and provide Lilly support as necessary
Dossier Management: Ensure timely provision of required submission dossiers to the Partners in assigned countries. Ensure maintenance of data in Lilly systems and electronic archives
Foster an environment of operational excellence and liaise cross-functionally within Lilly to agree submission strategy for new products, new indications, renewals and source changes/adds to match the commercial strategy agreed between Lilly and Business Partners
Oversee labelling projects to ensure new and updated printed packaging materials are available in line with timelines agreed with the Partner
Collaborate with Partners to ensure timely and clear dossier requirements are provided to Lilly support groups during submission planning
Liaise cross-functionally with Lilly and the External Partners to agree submission strategy for new products, new indications, renewals and source changes/adds
Ensure submission plans are created and maintained in Lilly Regulatory IT tools based on information from Partner
Facilitate implementation of the Regulatory Plan in alignment with Lilly and Partner business plans.
Work with global Lilly functions to obtain all required submission documents and ensure timely responses to Regulatory Authority requests received from the Partner
Voice Region and Partner perspective and requirements to global regulatory contacts. Coordinate feedback to ensure documents are as required by Partner and use regulatory expertise to provide creative solutions/alternatives in cases where Lilly is unable to meet requirements
Ensure provision of submission documents to Partner as per agreed timelines
Ensure archiving of electronic copies of submissions
Document submission plans and follow-up on progress of submission/timelines with assigned Partner(s) and periodically review with Partner’s performance metrics.
Represent Regulatory Affairs in Alliance (Regulatory and leadership) Meetings
Serve as regulatory point person for any queries from Partner
Serve as affiliate regulatory point person for queries from the business or global functions (GRA, Quality, Supply Chain, Manufacturing)
Ensure data maintenance and data integrity of internal Regulatory IT tools with defined compliance metrics..
Ensure implementation of local quality system in line with the global quality system and local regulations.
Support internal and external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.
Implement corrective/preventive actions as appropriate.
Raise awareness to leadership and relevant functions on compliance issues and initiatives.
Perform the function of Primary Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with Lilly Core Data Sheet.
Follow global labelling procedures to review Proposed Labelling for exceptions to Core Labelling and ensure all such exceptions are documented
Ensure timely creation of labelling projects in BLUE and liaise with Supply Chain and PPD to ensure new/revised labelling available in line with Partner’s timelines
Ensure alignment and implementation of internal regulatory initiatives.
Personal and Professional Development
Knowledge and understanding of local and regional regulations and local, regional and global regulatory procedures.
Attend appropriate external symposia, workshops or conferences to develop technical expertise
Minimum Qualification Requirements:
Bachelor's degree or equivalent in a relevant scientific subject
At least one year industry related experience in Regulatory Affairs.
Team working skills with special focus on results.
Ability to adapt to challenging situations.
Demonstrated good computer/IT skills.
Good knowledge of written and spoken English, French & Arabic.
Other Information/Additional Preferences:
Analytical, problem solving and negotiation skills.
Good communication skills.
Project management skills.
Strong planning and priority setting.
Good capability to establish positive networking both internally.
Strong knowledge of quality systems.