Ra Cmc Manager

0-2 years

Not Disclosed

Indianapolis

10 Nov. 27, 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

RA CMC Manager

Location: India
Job ID: REQ-10030411
Department: Regulatory Affairs (RA)

About the Role

The RA CMC Manager is responsible for leading regulatory activities related to Chemistry, Manufacturing, and Control (CMC), focusing on regulatory strategy, submission activities, and interactions with Health Authorities (HAs) for both new product and post-marketing launches.

Key Responsibilities

Global CMC Regulatory Strategy:
- Formulate and lead global CMC regulatory strategy, balancing innovation with regulatory compliance to maximize business benefits.
- Lead and manage all global CMC submission activities, including planning, authoring, reviewing, coordination, and submission for assigned projects/products.
Documentation & Compliance:
- Identify required documentation and resolve any content, quality, or timeline issues for global submissions.
- Author and/or review high-quality CMC documentation for HA submissions, ensuring alignment with global regulatory strategies, trends, and guidelines.
- Ensure technical congruency and regulatory compliance within agreed timelines and e-publishing requirements.
Risk Management & Health Authority Interaction:
- Prepare and communicate CMC Risk Management Assessments and contingency plans for major submissions.
- Initiate and lead Health Authority interactions and negotiations, setting objectives and preparing necessary materials (briefing books, rehearsals, risk mitigation plans).
Reporting & Compliance:
- Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours.
- Manage the distribution of marketing samples (if applicable).

Key Performance Indicators

High-quality strategic project documentation and presentations, with no late changes in strategy due to inadequate prior evaluation.
No delays in approvals for clinical studies, global registration dossiers, or variations due to late or inadequate submission documentation.
Reliable, timely, and accurate information provided to stakeholders regarding project documentation.
Regulatory compliance met in all compliance systems, with high-quality regulatory evaluations and advice delivered on time.

Minimum Requirements

Work Experience:
- Cross-cultural experience and operations management expertise.
- Strong project management skills and experience in collaborating across teams.
Skills:
- Change control management, cross-functional team coordination, and documentation management.
- Strong negotiation skills, risk assessment, and regulatory compliance knowledge.
Languages:
- Proficiency in English.

Why Novartis?

At Novartis, we’re dedicated to transforming the lives of patients and their families. Join a team of passionate individuals committed to achieving breakthroughs in healthcare.

Benefits and Rewards

Explore the extensive benefits and rewards designed to support your personal and professional growth: NovartisBenefits and Rewards.

Join Our Network

If this role doesn’t match your experience or career goals, join the Novartis Talent Network to stay connected and receive alerts for future opportunities: Novartis Talent Network.

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Ra Cmc Manager

Job Description

RA CMC Manager

About the Role

Key Responsibilities

Key Performance Indicators

Minimum Requirements

Why Novartis?

Benefits and Rewards

Join Our Network

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