Senior Associate Regulatory Affairs
Riyadh, Saudi Arabia
Job Description
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.
- Ensure submission and approval of high quality regulatory applications within planned timelines. Maintain or support maintenance of clear metrics for Regulatory deliverables.
- Preparation and support of new applications to obtain marketing authorisations.
- 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 bodies
Qualifications, Knowledge, Experience and Skills
Educational Qualifications
- Bachelor's degree in Pharmacy.
Knowledge and Experience
Core:
- Demonstrated ability to use Microsoft Office
Desired:
- Min of 4 year Regulatory experience
- 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
Desired
- 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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Job Detail
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Job IdJD1423679
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationRiyadh, Saudi Arabia
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EducationNot mentioned