Lead Regulatory Pharmacist

2 weeks ago

Bryanston, South Africa 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.

Regulatory Strategy:

  • Assist with the development and implementation of the Regulatory Plan and Strategy 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).
  • Actively participate in affiliate launch teams, anticipating and delivering regulatory outcomes to support the affiliate launch plans
  • Represent the Regulatory Affairs function as backup to the Regulatory and Quality Director when they are absent 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 crossfunctional experts as appropriate and implement locally.
  • Interact directly or facilitate interactions with regulatory bodies on a regular basis as appropriate.

Regulatory Compliance:

  • Ensure that internal Regulatory IT tools are up to date and accurate and actively use available tools to monitor regulatory plans for product and country portfolio.
  • Ensure that all products comply with local regulations and quality system requirements whichever is more stringent.
  • Ensure that the regulatory archive is complete and uptodate 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 / selfinspections in collaboration with Regulatory Quality personnel.
  • Assist with the coordination and Implementation of 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:

  • Identify local process improvement opportunities and ensure implementation of relevant local and global regulatory initiatives.
  • Actively participate in affiliate crossfunctional teams and provide regulatory status updates, input and knowledge.
  • Support implementation of launch readiness initiatives.
  • Facilitate 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 to improve and maintain understanding of regulatory affairs within affiliate leadership.

Personal and Professional Development:

  • Knowledge and understanding of local regulations and local, regional and global regulatory procedures.
  • Assist in creating and maintaining a positive and effective working environment and assist team members in extending their technical skills.
  • Manage own performance and development by actively setting and meeting individual professional development goals
  • Attend appropriate external symposia, workshops or conferences to develop and sustain an appropriate level of technical and professional expertise.


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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