Requirement of Group Head - Global Labeling (Drug Regulatory Affairs) @ Novartis

Pharma Admission

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3. Process Improvements: Contribute to and / or lead management and continuous improvement initiatives
4. Member of GL Leadership Team:
a. As a member of the Global Labelling Leadership Team, contribute to the overall strategic direction of the department by active contribution to GL Management meetings and GL Departmental Meetings.
a. Represent DRA GL at internal boards and committees, and during internal audits and external inspections.
b. Review and comment emerging internal and external guidelines and regulations on regulatory, safety, and legal topics.
c. Deputise for Head Global Labelling, as appropriate, e.g. at DRA Management meetings, Portfolio Stewardship Board Meetings, Chairing the Global Labelling Committee.

Key Performance Indicators
1. Lead: Meet the KPIs of the project- timelines, quality, productivity
2. People management- timely completion of performance appraisals, feedback from group
3. Team player- Assessed from global multi-rater feedback (including GLC)

Job Dimensions
Number of associates:
Approx. 25 associates (12-16 direct reports)

Financial responsibility:
(Budget, Cost, Sales, etc.)
None

Impact on the organization: For assigned products:
To ensure harmonized worldwide labelling through a common Core Data Sheet.
To ensure patient safety through timely and adequate updates of core safety information.
To ensure compliance with internal policies on labelling.
To minimize litigation risks associated to product liability, by overseeing the local implementation of labelling changes worldwide.
To protect worldwide sales and Novartis reputation by ensuring appropriate product labelling worldwide.
To minimise risk of discontinuation of marketed products worldwide due to inappropriate labelling.

Candidate Profile:
Ideal Background

Education: Minimum: MSc in Life Sciences/ M Pharm

Desired: Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent), or PhD in Life Sciences
MSc/ M Pharm with minimum 8 years experience in DRA, Medical Information or Project Management; proven Leadership

Desired: MBBS/ PhD with at least 6 years of Regulatory/ Medical Writing/ Drug safety work experience.

Experience for handling team for at least 3 years

Languages: Excellent written and oral English

Additional Information:
Experience: 8-9 Years
Location:
Hyderabad
Education: B.Pharm, M.Pharm, B.Sc, M.Sc-Life Sciences, Ph.D, MBBS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area:
DRA
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID:
85815BR
End Date: 23rd Oct., 2011

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