Regulatory Affairs Associate

3 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 Associate role is to execute the operational aspects of regulatory affairs for the marketing affiliate, including:

- License maintenance activities (e.g. Labelling changes, CMC Changes, Renewals)
- New registrations, line extensions and new indications.
- Tracking regulatory procedures and archiving correspondence in accordance with local Saudi regulations and quality system requirements.
- Provide operational excellence to successfully achieve Affiliate regulatory objectives.
- Facilitate and cultivate relationships with relevant external regulatory personnel.

Main Accountability/responsibility

Regulatory Plan Execution
- Collaborate with the implementation of the Regulatory Plan in alignment with affiliate business plans as well as with regulatory requirements.
- Coordinate administrative tasks (i.e. translations, legalizations, etc.) to facilitate dossier preparation.
- Execute maintenance activities for marketing authorizations (timely submission of post approval maintenance activities like renewals, variations and periodic reports).
- Support Dossier assembly in compliance with local regulations and quality system requirements.
- Maintain awareness of current regulations and upcoming changes in the regulatory environment. Communicate changes to appropriate management and cross-functional experts as appropriate and implement locally.

Regulatory Compliance
- Keep internal Regulatory IT tools up to date and accurate
- Ensure that all products & medical devices comply with local regulations and quality system requirements whichever is more stringent.
- Keep the regulatory archive complete and up-to-date and ensure that all current licenses and labels are readily available
- Support implementation of local quality system in line with the global quality system and local regulations.
- Support internal/external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.
- Raise awareness on compliance issues with leadership and relevant functions.

Labelling
- Perform the function of Affiliate Labelling Responsible Person, 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
- Support implementation of relevant internal regulatory 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 bodies

Qualifications, Knowledge, Experience and Skills

Educational Qualifications

Core:

- Bachelor's degree in Pharmacy.
- Demonstrated ability to use Microsoft Office
- Strong communication skills
- Strong command of English language (written and spoken)
- Ability to work within a team and deliver results
- Planning & Organizing
- Time Management
- Must be legally allowed to work in KSA
- Saudi Nationals only

Desired:

- Min of 2 years Regulatory experience
- Good capability to establish positive networking both internally and externally.
- Knowledge of Quality systems
- Ability to adapt to difficult and different challenges

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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