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 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.

Primary Responsibilities:

Regulatory Strategy

· Develop and Implement the Regulatory Plan and Strategy in alignment with affiliate business plans as well asregulatory requirements.

· Ensure submission and approval of high quality regulatory applications within planned timelines. Maintain clear metricsfor Regulatory deliverables.

o Preparation and support of new applications to obtain marketing authorisations.

o Voicing affiliate perspective and needs to global and regional regulatory contacts.

o Ensuring timely responses to requests from support groups and/or Regulatory Authorities.

o Maintaining marketing authorisations (timely submission of post approval maintenance activities like renewals,variations and periodic reports)

· Actively participate in the affiliate launch teams, anticipating and delivering regulatory outcomes to support the affiliate launch plan.

· Represent the Regulatory Affairs function as appropriate in Affiliate Lead Team, New Product Planning discussions

· Represent Lilly in external industry meetings.

· 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.

· 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.

· Ensure that all products comply with local regulations and quality system requirements whichever is more stringent.

· Implement robust processes to keep regulatory archive complete and up-to-date and to ensure that all current licenses and labels are readily available.

· Create, implement and maintain local quality system in line with the global quality system and local regulations.

· Manage and support internal and external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.

· Lead and coordinate implementation of corrective/preventive actions as appropriate.

· Lead regulatory quality oversight of 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.

· Ensure adherence with 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 global regulatory initiatives.

· Consistently participate in affiliate cross-functional teams and provide regulatory status updates, input and knowledge.

· Ensure alignment and 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.

· Create and maintain a positive and effective working environment and, if applicable, effectively lead, manage, motivate and mentor the Regulatory Affairs team and assist direct reports in extending their technical skills. Assure key talent retention, development, reward, and recognition.

· 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 professional expertise

Minimum Qualification Requirements:

· Bachelor's degree or equivalent in a relevant scientific subject.

· Over 8 years industry related experience in regulatory affairs and experience of dealing with external regulatory agencies, the health care system and marketing needs.

· Team working skills with special focus on results and internal customers.

· Ability to adapt to challenging situations.

· Demonstrated good computer/IT skills.

· Project management skills.

· Strong analytical, problem solving and negotiation skills.

· Good knowledge of written and spoken English.

Other Information/Additional Preferences:

· People management & leadership experience

· First class communication skills.

· Excellent planning and priority setting.

· Strategic thinking.

· Strong capability to establish positive networking both internally and externally.

· Strong knowledge of quality systems.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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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