Associate Director-Regulatory Liasoning

Lilly

8+ years

Not Disclosed

Gurgaon

10 Jan. 1, 2025

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

Join Us at Lilly: Associate Director - Regulatory Affairs and Liaisoning

At Lilly, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, we are a global healthcare leader dedicated to discovering and delivering life-changing medicines. Our employees are passionate about improving disease management and giving back to communities through philanthropy and volunteerism. We put people first and are seeking individuals who are committed to making a global impact.

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 be responsible for regulatory liaisoning and managing regulatory activities with key bodies in India, such as 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), Central Drugs Testing Laboratory (CDTL), and other relevant authorities at both central and state levels. This role involves ensuring compliance with local regulations, facilitating communication between the company and regulatory bodies, and supporting pharmaceutical product registration and maintenance.

Key Responsibilities:

Regulatory Compliance: Ensure all activities comply with local regulations and guidelines set by CDSCO, MoHFW, NIB, IPC, CDTL, and other relevant authorities.
Liaison with Regulatory Bodies: Act as the primary contact between the company and regulatory authorities, ensuring smooth communication and addressing regulatory queries or issues.
Product Registration: Manage the product registration process, including new products, line extensions, and new indications, ensuring timely submission and approval of dossiers.
Documentation: Prepare, review, and submit regulatory documents, including applications, variations, renewals, and responses to queries from regulatory authorities.
Regulatory Strategy: Develop and implement regulatory strategies to align with the company’s business goals and ensure successful product registrations.
Cross-Functional Collaboration: Work closely with internal departments such as R&D, Quality Assurance, and Marketing to ensure alignment on regulatory requirements and timelines.
Regulatory Intelligence: Monitor and analyze changes in regulatory policies and guidelines, providing updates and recommendations to management.
Training and Development: Provide training and guidance on regulatory requirements and best practices.
Stakeholder Management: Build and maintain relationships with government officials, industry associations, and other key stakeholders.
Risk Management: Identify potential regulatory risks and develop strategies to ensure compliance and minimize business impact.

Qualifications:

Core: Bachelor’s degree in pharmacy, Life Sciences, or a related field; advanced degree preferred.
Experience: Minimum of 8 years in regulatory affairs within the pharmaceutical industry, preferably in a multinational company (MNC).
Knowledge: In-depth knowledge of Indian regulatory requirements, particularly CDSCO, MoHFW, NIB, IPC, CDTL, and other relevant authorities.
Skills: Strong communication and interpersonal skills, organizational and project management skills, and proficiency in regulatory documentation and submission processes.

Preferred Skills:

Experience in regulatory liaison roles.
Familiarity with global regulatory requirements.
Ability to work independently and collaboratively within a team.
Strong analytical and problem-solving skills.

Lilly is committed to promoting diversity and inclusion. We ensure equal opportunities for individuals with disabilities and provide reasonable accommodation during the application process. For accommodation requests, please complete the accommodation request form.

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.

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Associate Director-Regulatory Liasoning

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