Regulatory Affairs Manager

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 39,000 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.

Key Responsibilities:

1.Regulatory Plan Execution

Implement the Regulatory Plan in alignment with affiliate business plans as well as regulatory requirements.

1.1 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 authorizations.

• 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)

1.2 Maintain Regulatory Tools in alignment with defined compliance metrics.

1.3 Support Affiliate launch Teams anticipating potential regulatory constraints and delivering regulatory outcomes to support the affiliate launch plans.

1.4 Represent the Regulatory Affairs function as appropriate in Affiliate Lead Team and New Product Planning discussions

1.5 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.

1.6 Facilitate interactions with regulatory bodies on a regular basis.

2. Regulatory Compliance

2.1 Ensure that internal Regulatory IT tools are up to date and accurate.

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

2.3 Ensure that the regulatory archive is complete and up-to-date and that all current licenses and labels are readily available.

2.4 Ensure implementation of local quality system in line with the global quality system and local regulations.

2.5 Support internal and external audits / assessments / self-inspections in collaboration with Regulatory Quality personnel.

2.6 Implement corrective/preventive actions as appropriate.

2.7 Provide regulatory quality oversight for Third Parties (i.e. Regulatory Services Providers, Translators, Graphic Agencies, etc.) as appropriate.

2.8 Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions.

3. Labelling

3.1 Perform the function of Primary 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.

3.2 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.

4. Process Improvement

4.1 Ensure alignment and implementation of internal regulatory initiatives.

4.2 Actively participate in affiliate cross-functional teams and provide regulatory input and knowledge.

4.3 Support implementation of launch readiness initiatives.

4.4 Build and maintain relationships with key regulatory officials (External Influence).

4.5 Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives.

5. Personal and Professional Development

5.1 Knowledge and understanding of local regulations and local, regional and global regulatory procedures.

5.2 Attend appropriate external symposia, workshops or conferences to develop technical expertise.

Additional responsibilities

Patient Safety

• Assist the Affiliate Pharmacovigilance Responsible Person in reporting received Adverse Events and submitting expedited and periodic safety reports to the Agency/MoH as per local regulations.

Product Quality

• Assist the Product Quality Representative with the implementation and execution of Lilly Global Quality Standards in the affiliate. Identify and support Product Quality tasks and, in collaboration with the Product Quality

Representative, act as the local Quality contact.

• Support the Product Complaint system as local Responsible Complaint person.

Qualification:

• Bachelor's degree or equivalent in a relevant scientific subject

• At least 3-5 years of industry related experience in regulatory affairs and experience of dealing with external regulatory agencies, the health care system and marketing needs

Skills & Knowledge:

• Team working skills with special focus on compliance and results

• Ability to work with people at difference levels

• Ability to adapt to challenging situations

• Demonstrated good computer/IT skills

• Good knowledge of written and spoken English

• Analytical, problem solving and negotiation skills

• Good communication skills

• Project management skills

• Strong planning and priority setting

• Good capability to establish positive networking both internally and externally

• Strong knowledge of quality systems

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 ( [email protected] ) 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.