Regulatory Affairs Associate

9 سبتمبر، 2022

0 4 3 دقائق

الوصف الوظيفي

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.
Support submission of high-quality regulatory applications within planned timelines.

Support dossier preparation of new applications to obtain marketing authorisations.
Coordinate administrative tasks (i.e. translations, legalizations, etc.) to facilitate dossier preparation.
Execute maintenance activities for marketing authorisations (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 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

Bachelor's degree in Pharmacy.

Knowledge and Experience

Core

Min of 2 year Regulatory experience
Demonstrated ability to use Microsoft Office
Good capability to establish positive networking both internally and externally.
Knowledge of Quality systems

Skills

Core

Strong communication skills
Strong command of English language (written and spoken)
Ability to work within a team and deliver results
Planning & Organizing
Time Management

Desirable

Ability to adapt to difficult and different challenges

Other role requirements

Must be legally allowed to work in KSA
Will require domestic travel, and may require international travel
May require evening/weekend work
Saudi Nationals only

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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