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Associate Director-Regulatory Liasoning

7+ years
Not Disclosed
10 Nov. 19, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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 are dedicated to discovering and delivering life-changing medicines, improving disease understanding and management, and contributing to communities worldwide through philanthropy and volunteerism. We give our best effort in all we do and prioritize people first. We’re looking for individuals determined to make a meaningful impact on global healthcare.

Job Title: Associate Director - Regulatory Affairs and Liaisoning
Location: Gurgaon, Haryana, India
Reports to: Director - Regulatory Affairs & Pharmacovigilance

Job Summary:
The Associate Director - Regulatory Affairs will oversee regulatory liaison activities and manage regulatory coordination with key bodies in India. This includes the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare (MoHFW), Department of Pharmaceuticals, National Institute of Biologicals (NIB), Indian Pharmacopoeia Commission (IPC) Ghaziabad, Central Drugs Testing Laboratory (CDTL), and other government entities at central and state levels. The role ensures regulatory compliance, facilitates communication between Lilly and regulatory bodies, and supports product registration and maintenance.

Key Responsibilities:

  • Regulatory Compliance: Ensure adherence to local regulations and guidelines set by CDSCO, MoHFW, NIB, IPC Ghaziabad, CDTL, and other relevant authorities.
  • Liaison with Regulatory Bodies: Serve as the main point of contact between Lilly and regulatory agencies, handling communication and resolving regulatory issues.
  • Product Registration: Manage registration for new products, line extensions, and new indications, ensuring timely submissions and approvals.
  • Documentation: Prepare, review, and submit regulatory documents, including applications, variations, renewals, and responses to regulatory queries.
  • Regulatory Strategy: Develop strategies aligned with the company’s goals to support successful product registrations.
  • Cross-functional Collaboration: Coordinate with R&D, Quality Assurance, and Marketing teams to ensure alignment with regulatory requirements and timelines.
  • Regulatory Intelligence: Track changes in regulations and guidelines, providing updates and strategic recommendations to management.
  • Training and Development: Provide training to internal teams on regulatory processes and best practices.
  • Stakeholder Management: Cultivate and maintain relationships with key stakeholders, including government representatives, industry groups, and other entities.
  • Risk Management: Identify potential regulatory risks and develop strategies to mitigate them, ensuring minimal business disruption.

Qualifications:

  • Bachelor’s degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred.
  • Minimum of 8 years of experience in regulatory affairs within the pharmaceutical industry, preferably with an MNC.
  • Extensive knowledge of Indian regulatory requirements, including those of CDSCO, MoHFW, NIB, IPC Ghaziabad, and CDTL.
  • Strong communication and interpersonal skills, capable of building relationships with regulatory authorities.
  • Excellent organizational and project management skills with the ability to manage multiple tasks and deadlines.
  • Proficiency in regulatory documentation and submission processes.

Preferred Skills:

  • Experience in regulatory liaison or similar roles.
  • Familiarity with global regulatory requirements.
  • Ability to work independently and collaboratively in a team.
  • Strong analytical and problem-solving abilities.

Lilly is dedicated to providing equal opportunities for individuals with disabilities. If you need accommodation to submit a resume, please complete the accommodation request form. This form is specifically for accommodation requests during the application process, and any other inquiries will not receive a response.

Lilly does not discriminate based on 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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