Manager / Senior Manager - Regulatory Affairs - Gurgaon, Haryana
Location: Gurgaon, Haryana, India
Category: Research & Development
Job Type: Full Time, Regular
Job Id: R-78426
Company Overview:
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 worldwide 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.
Primary Responsibilities:
Regulatory Plan Execution:
Implement the Regulatory Plan in alignment with affiliate business plans and regulatory requirements.
Ensure submission and approval of high-quality regulatory applications within planned timelines.
Maintain or support maintenance of clear metrics for Regulatory deliverables.
Prepare and support new applications to obtain marketing authorizations.
Ensure timely responses to requests from support groups and/or Regulatory Authorities.
Maintain marketing authorizations (post-approval maintenance activities like renewals, variations, and periodic reports).
Support affiliate launch teams by anticipating potential regulatory constraints and delivering regulatory outcomes to support affiliate launch plans.
Represent the Regulatory Affairs function in Affiliate Lead Team and New Product Planning discussions.
Regulatory Compliance:
Ensure that internal Regulatory IT tools are up-to-date and accurate.
Ensure all products comply with local regulations and quality system requirements.
Maintain a complete and up-to-date regulatory archive with all current licenses and labels.
Support internal and external audits/assessments/self-inspections with Regulatory Quality personnel.
Provide regulatory quality oversight for Third Parties (Regulatory Service Providers, Translators, Graphic Agencies, etc.).
Raise awareness to leadership and relevant functions on compliance issues and initiatives.
Labelling:
Act as the Primary, Alternate, or Delegate Affiliate Labelling Responsible Person (ALRP).
Ensure Product Information complies with local regulatory requirements.
Follow global labelling procedures to produce accurate and high-quality Product Information 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.
Provide affiliate training and education on regulatory matters.
Optional Responsibilities:
Assist the Affiliate Pharmacovigilance Responsible Person in reporting Adverse Events and submitting safety reports to the Agency/MoH.
Assist the Product Quality Representative with the implementation and execution of Lilly Global Quality Standards.
Support the Product Complaint system as the local Responsible Complaint Person.
Minimum Qualification Requirements:
Bachelor's degree or equivalent in a relevant scientific subject.
At least one year of industry-related experience in regulatory affairs and experience dealing with external regulatory agencies.
Team working skills with a focus on results.
Ability to adapt to challenging situations.
Good computer/IT skills.
Strong knowledge of written and spoken English.
Additional Preferences:
Analytical, problem-solving, and negotiation skills.
Strong communication skills.
Project management and priority-setting skills.
Ability to establish positive networking internally and externally.
Strong knowledge of quality systems.
Equal Opportunity Statement:
Lilly is dedicated to ensuring equal opportunities for individuals with disabilities in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form for assistance.
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.
#WeAreLilly
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