Add office photos
All Filters
233 Novartis Jobs
QA Compliance Expert - Reg CMC Facilitator
3-5 years
Hyderabad / Secunderabad
1 vacancy
QA Compliance Expert - Reg CMC Facilitator
Novartis
posted 4mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Key Responsibilities:
- Maintaining close cooperation with RA CMC to discuss regulatory requirements, strategies and knowledge of global product dossiers to stay up-to-date.
- Conducting training to ensure appropriate knowledge and regulatory compliance.
- Supporting the area in effective change control. Examination of reg. relevance and pre-evaluation amendments to Novartis products and customer products.
- Contact person for regulatory matters and intermediary between RA CMC and production unit at strategy decisions and in the product life cycle.
- Support of timely reviews of CMC documents for defined products; Support with and Identification of challenges in the course of regulatory compliance audits.
- Implementation and overview of initiatives to improve (regulatory) compliance.
- Coordination, guidance, and support in the preparation of CMC responses to health authorities for specific products.
- Advanced University or academic degree in chemistry, biology, pharmacy, engineering or equivalent.
- Fluent English (German desired).
- More than 3 years of experience in an operational GxP area, in Manufacturing, Development or QA or Regulatory Affairs; with a thorough knowledge of biologic drug substance manufacturing processes for recombinant proteins and/or nucleic acids.
- Ability to speak up and to take Quality decisions during challenging situations.
- Expertise in organization dynamics and culture, ability to gain trust and confidence at all levels in the organization, leadership, and project management experience.
- Ability to work independently and effectively in international, complex, and multifaceted environments.
Employment Type: Full Time, Permanent
Read full job descriptionPrepare for Facilitator roles with real interview advice
People are getting interviews at Novartis through
People are getting interviews through
(based on 101 Novartis interviews) What people at Novartis are saying
What Novartis employees are saying about work life
Novartis Benefits
View more benefits
Compare Novartis with
GlaxoSmithKline Pharmaceuticals
Sun Pharmaceutical Industries
Cipla
Dr. Reddy's
Pfizer
Biocon Limited
Aurobindo Pharma
Lupin
Zydus Lifesciences
Torrent Pharmaceuticals
Viatris
Abbott
Alkem Laboratories
Ipca Laboratories
Glenmark Pharmaceuticals
Akums Drugs & Pharmaceuticals Limited
DIVI'S Laboratories
Piramal Group
Sanofi
Fresenius Kabi
Similar Jobs for you
Novartis Hyderabad / Secunderabad Office Location
Telangana 500081
Clinical Sourcing Manager - Medical Affairs
3-6 Yrs
Hyderabad / Secunderabad
Assistant Manager - Financial Compliance Standards & Governance
4-8 Yrs
Hyderabad / Secunderabad
