Ra Cmc Associate Manager Ii

0-2 years

Not Disclosed

India

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 Associate Manager II

Location: India
Job ID: REQ-10030417
Department: Regulatory Affairs (RA)

About the Role

The RA CMC Associate Manager II is responsible for regulatory activities related to Chemistry, Manufacturing, and Control (CMC). This includes preparing and submitting CMC documentation to Health Authorities (HA) and addressing regulatory queries to support new product or post-marketing launches.

Key Responsibilities

Regulatory Documentation & Strategy:
- Author high-quality global CMC documentation for HA submissions across the product lifecycle, applying global regulatory strategies and guidelines.
- Ensure technical congruency and regulatory compliance within agreed timelines and e-publishing requirements.
Documentation Management:
- Identify required documents and resolve content, quality, or timeliness issues for global submissions, coordinating the delivery of approved technical source documents as per project timelines.
- Collect and store source documentation needed for direct submission to Health Authorities.
Collaboration & Regulatory Strategy:
- Actively contribute to the global RA CMC team, identifying critical issues and lessons learned to improve regulatory strategy.
- Participate in regulatory meetings and provide support for department activities like data entry into Regulatory Information Management Systems and other operational activities.
Compliance & Reporting:
- Ensure compliance with Novartis guidelines and regulatory requirements.
- Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours.
- Manage the distribution of marketing samples (where applicable).

Key Performance Indicators

High-quality regulatory documentation is submitted on time, with no delays in clinical study approvals, global registration dossiers, or variations.
Reliable, timely, and accurate communication with stakeholders regarding project documentation issues.
Build and maintain collaborative partnerships across teams and stakeholders.

Minimum Requirements

Work Experience:
- Cross-cultural experience and project management expertise.
- Strong skills in operations management, collaborating across boundaries, and documentation management.
Skills:
- Lifesciences and regulatory compliance knowledge.
- Demonstrated operational excellence in managing regulatory activities.
Languages:
- Proficiency in English.

Why Novartis?

At Novartis, we are committed to helping people with disease and their families. Join a team of passionate individuals working together to achieve breakthroughs that change patients’ lives.

Benefits and Rewards

Explore the wide range of benefits and rewards that support your personal and professional growth: Novartis Benefitsand Rewards.

Join Our Network

If this role isn’t the right fit for you, sign up for the Novartis Talent Network to stay connected and be alerted to future opportunities: Novartis Talent Network.

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Ra Cmc Associate Manager Ii

Job Description

RA CMC Associate Manager II

About the Role

Key Responsibilities

Key Performance Indicators

Minimum Requirements

Why Novartis?

Benefits and Rewards

Join Our Network

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