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1 Novartis Regulatory Affairs Manager Job
Regulatory Affairs Manager; Labeling
8-13 years
Hyderabad / Secunderabad
1 vacancy
Regulatory Affairs Manager; Labeling
Novartis
posted 2mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
-Provides the labeling/artwork strategy, regulatory intelligence and knowledge which are required to develop, market, and maintain products. Provides strategic labeling input and support for global development projects and/or marketed products.
Reviews labeling change information, and ensures that it is supported by the data and consistent with the application. Supports and assists the development and participates in negotiations on later stage products with regulatory agencies on approval of label. Monitors, evaluates and recommends improvements to labeling processes, quality, systems tools and/or policies.
Major accountabilities:
- Review and assess local country labels to identify deviations from the core labeling and propose topics for further cross-functional assessment during the periodic core labeling review process -Contribute to DRA activities regarding Novartis safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products.
- Contribute to the creation of high quality documents supporting changes with internal and/or external experts including the preparation of responses to labeling related Health Authority queries -Ensure that key country label proposals which deviate from a proposed CDS or CDS amendment/update (e.g., US PI, EU SmPC) are brought to the attention -A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
- Networks with senior internal and external personnel in own area of expertise.
- 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:
- Adherence to Novartis policy and guidelines -Project & stakeholder feedback
Minimum Requirements:
Work Experience:
Work Experience:
- Cross Cultural Experience.
- People Challenges.
- Functional Breadth.
- Project Management.
- Collaborating across boundaries.
Skills:
- Cross-Functional Teams.
- Detail Oriented.
- Labeling Documentation.
- Labeling Regulations.
- Operational Excellence.
- Regulatory Compliance.
- Safety.
Languages :
- English.
Employment Type: Full Time, Permanent
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(based on 103 Novartis interviews)
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33%
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14%
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3%
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17% candidates got the interview through other sources.
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What Regulatory Affairs Manager at Novartis are saying
Rating based on 2 Regulatory Affairs Manager
reviews
Anonymous · Legal Operations
in Hyderabad
Likes
Work culture
Dislikes
Nothing that I dislike
Read 2 reviewsRegulatory Affairs Manager salary at Novartis
reported by
20
employees
with 8-13
years exp.
₹10.2
L/yr - ₹31
L/yr
27%
more
than the average Regulatory Affairs Manager Salary in India
View more details
What Novartis employees are saying about work life
based on 1.5k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Novartis Benefits
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Novartis Hyderabad / Secunderabad Office Location
Hyderabad Office
Novartis, Salarpuria-Sattva Knowledge City, Madhapur, Madhapur, Inorbit Mall Rd, Silpa Gram Craft Village, HITEC City
Hyderabad
Telangana 500081
Telangana 500081
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