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300 Novartis Jobs

RA CMC Associate Manager-II

2-4 years

Hyderabad / Secunderabad

1 vacancy

RA CMC Associate Manager-II

Novartis

posted 6mon ago

Job Description

Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches.
About the Role
Major accountabilities:
  • Author high quality global CMC documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines.
  • Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
  • Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • As needed, coordinate /collect /store source documentation needed for direct submission to Health Authorities.
  • Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
  • Perform activities in support of the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed.
  • Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
  • Produces high quality regulatory documentation -No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control.
  • Delivers reliable, timely & accurate information / communication about project documentation specific issues within own department and to key stakeholders.
  • RA CMC regulatory documentation follows Novartis guidelines & meets regulatory guidelines.
  • Builds & maintains collaborative partnerships with stakeholders.
Minimum Requirements:
Work Experience:
  • Cross Cultural Experience.
  • Project Management.
  • Operations Management and Execution.
  • Collaborating across boundaries.
Skills:
  • Documentation Management.
  • Lifesciences.
  • Operational Excellence.
  • Regulatory Compliance.
Languages :
  • English.

Employment Type: Full Time, Permanent

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What people at Novartis are saying

4.4
 Rating based on 14 Associate Manager reviews

Likes

Awesome step in career

  • Skill development - Excellent
  • +4 more
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Dynamics in business can percolate to the associate level.

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Associate Manager salary at Novartis

reported by 150 employees with 4-15 years exp.
₹7 L/yr - ₹22 L/yr
8% more than the average Associate Manager Salary in India
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What Novartis employees are saying about work life

based on 1.6k employees
89%
76%
54%
98%
Flexible timing
Monday to Friday
No travel
Day Shift
View more insights

Novartis Benefits

Health Insurance
Work From Home
Free Transport
Cafeteria
Soft Skill Training
Gymnasium +6 more
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Novartis Hyderabad / Secunderabad Office Location

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Hyderabad Office
Novartis, Salarpuria-Sattva Knowledge City, Madhapur, Madhapur, Inorbit Mall Rd, Silpa Gram Craft Village, HITEC City Hyderabad
Telangana 500081

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