Job Title: Manager / Senior Manager - Regulatory Affairs
Location: Gurgaon, Haryana, India
Category: Research & Development
Job Type: Full Time Regular
Job ID: R-78426
About Eli Lilly:
Eli Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, committed to discovering and delivering life-changing medicines. The company works across various therapeutic areas to bring innovative treatments to patients worldwide while improving disease understanding and management. Lilly emphasizes both science and philanthropy to support the health and well-being of individuals globally.
Position Overview:
The Manager/Senior Manager of Regulatory Affairs is responsible for managing the operational and technical aspects of regulatory affairs for the marketing affiliate. This role ensures the success of new product registrations, line extensions, and indications, in alignment with affiliate business plans, while maintaining compliance with local regulations and quality system requirements.
Key Responsibilities:
Regulatory Plan Execution:
Implement the regulatory plan to meet business and regulatory objectives.
Prepare, submit, and support regulatory applications, ensuring timely approvals.
Maintain metrics for regulatory deliverables, ensuring compliance with regulations and local quality systems.
Support affiliate launch teams and anticipate regulatory challenges to align with affiliate launch plans.
Regulatory Compliance:
Ensure that all products comply with local regulations and quality system requirements.
Maintain up-to-date regulatory archives and current licenses.
Facilitate internal and external audits, ensuring compliance with global and local regulations.
Provide oversight for regulatory services providers (e.g., translators, graphic agencies) to ensure compliance.
Labeling and Documentation:
Perform as the primary or alternate Affiliate Labelling Responsible Person (ALRP).
Ensure compliance with local regulatory requirements for product information, submitting and implementing updated labels as required.
Process Improvement:
Participate in affiliate cross-functional teams to provide regulatory input.
Lead regulatory education and training sessions within the affiliate.
Build and maintain relationships with regulatory authorities and officials.
Optional Responsibilities:
Support Pharmacovigilance and Product Quality functions in managing adverse event reports, product complaints, and quality standards.
Qualifications:
Required:
Bachelor's degree or equivalent in a relevant scientific field.
At least one year of industry experience in regulatory affairs, including dealing with external regulatory agencies.
Strong computer/IT skills.
Proficiency in written and spoken English.
Ability to work in cross-functional teams and adapt to challenging situations.
Additional Preferences:
Strong analytical, problem-solving, and negotiation skills.
Project management experience and good communication skills.
Knowledge of quality systems and ability to prioritize tasks effectively.
Equal Opportunity Employer:
Eli Lilly supports a diverse workforce, ensuring equal opportunities for individuals with disabilities. If you need accommodation during the application process, please complete the accommodation request form on Lilly’s career page.
Lilly does not discriminate on the basis of age, race, gender, disability, or other protected statuses.
How to Apply:
For more details or to apply, visit Eli Lilly Careers.
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Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Digha | Kolkata | Mukundapur |Alabama :
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King Abdullah Economic City | Jeddah | Riyadh | Najran | Khulais | Rabigh |Nišava District :
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