Regulatory Affairs Manager

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.

**PURPOSE**
- Supervise the Regulatory Affairs Department 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 (whichever is more stringent).
- Foster an environment of operational excellence through regulatory expertise and, if relevant, managing and developing direct reports and collaborating with cross-functional teams to successfully achieve Affiliate regulatory objectives.
- Facilitate and cultivate external relationships with the relevant Government bodies and industry associations.

**PRIMARY RESPONSIBILITIES**

**Regulatory Strategy**
- Develop and Implement 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 authorizations (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