Senior Associate Regulatory Affairs

5 days ago

Riyadh, Saudi Arabia Eli Lilly Full time

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.

Job summary

The purpose of the Affiliate Regulatory Affairs role is to manage the operational and technical aspects of regulatory affairs for the marketing affiliate, including:

- Execute the Regulatory Plan to ensure the success of new product registration, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements.
- Foster an environment of operational excellence and collaborate with cross-functional teams to successfully achieve Affiliate regulatory objectives.
- Facilitate and cultivate relationships with the local regulatory agency/MoH.

Main Accountability/responsibility

Regulatory Plan Execution
- Implement the Regulatory Plan in alignment with affiliate business plans as well as regulatory requirements.
- Voicing affiliate perspective and needs to global and regional regulatory contacts.
- Ensuring timely responses to requests from support groups and/or Regulatory Authorities.
- Maintaining marketing authorisations (timely submission of post approval maintenance activities like renewals, variations and periodic reports)
- Maintain Regulatory Tools in alignment with defined compliance metrics.
- Support Affiliate launch Teams anticipating potential regulatory constraints and delivering regulatory outcomes to support the affiliate launch plans.
- Represent the Regulatory Affairs function as appropriate in Affiliate Lead Team and New Product Planning discussions
- Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally.
- Facilitate interactions with regulatory bodies on a regular basis.

Regulatory Compliance
- Ensure that internal Regulatory IT tools are up to date and accurate.
- Ensure that all products comply with local regulations and quality system requirements whichever is more stringent.
- Ensure that the regulatory archive is complete and up-to-date and that all current licenses and labels are readily available.
- 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.
- Provide regulatory quality oversight for Third Parties (i.e. Regulatory Services Providers, Translators, Graphic Agencies, etc.) as appropriate.
- Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions.

Labelling
- Perform the function of Primary, Alternate or Delegate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or MOH timelines.
- Follow global labelling procedures and document relevant exceptions in order to produce accurate and high quality Product Information which is in compliance with global core labeling

Process Improvement
- Ensure alignment and implementation of internal regulatory initiatives.
- Actively participate in affiliate cross-functional teams and provide regulatory input and knowledge.
- Support implementation of launch readiness initiatives.
- Build and maintain relationships with key regulatory officials (External Influence).
- Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives.

Personal and Professional Development
- Keep up to date on knowledge and understanding of local regulations and local, regional and global regulatory procedures, to include where applicable attendance to MOH meetings focused on regulatory/regulations
- Keep up to date on trainings for professional development, to include external regulatory trainings
- Ensure Performance objectives are completed in line with company process (MyPM)
- Understanding and adherence to all company policies and procedures

Key Relationships

Internal
- Medical Team
- Sales Team
- Market Access Team
- Marketing Team
- HR team
- Finance Team
- Global Regulatory teams

External
- SFDA
- MOH
- Other Regulatory bo

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