A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Regulatory Manager II/ III, Emerging Diseases Franchise
Job Description:
Job Purpose (State in 2-3 sentences the overall objective / main purpose of the job)
Provide and manage regulatory support to the company in order to obtain Marketing Au-thorisations for commercial products as rapidly as possible and to maintain these authorisations. Provide input into all stages of the company’s development and portfolio products and develop strategies to ensure a complete and rapid development.
Manage the preparation of Regulatory Documentation, as well as give Regulatory input into the creation/execution of Regulatory.
Provide general oversight, training and development to Regulatory Affairs team at the Hyderabad site.
Major Accountabilities (Describe the main results / responsibilities of the job to be achieved)
- In this function, he/she is responsible for regulatory activities for his/her projects and prod-ucts.
- Organise the area of responsibility and managing, training, developing the respective group members within the Emerging Diseases Franchise along with the greater Regulatory Team in Hyderabad
- Liaise with Global Head of Regulatory Affairs, Functional RA Heads and Hyderabad site head on department wide training and development initiatives
- Maintain accuracy of budget and budget expenses for his/her group related activities
- Contact point for the concerned products/projects.
- Close co-operation with other concerned functions of the company, e.g. Medical, Commer-cial, Legal. (In cases TechOps/QA/QC on specific product issues or via Reg CMC)
- Collaborate with the other RA functions (e.g. Reg CMC, Reg Operations, Regional RA) re-garding regulatory submissions.
- Coordinate regulatory procedures such as clinical trials applications, marketing and manu-facturing authorisation applications, variations, annual reports, renewals, etc.
- Sit on designated project teams and providing regulatory input to these teams including preparation of draft position papers on regulatory issues, draft regulatory sections of project plans and suggested regulatory strategies.
- Provide regulatory advice within the framework of the company’s Change Control procedure, and to support the company’s regulatory compliance personnel.
- Regulatory approval of promotional material as required and helping to resolve external medical/technical enquiries.
- Assist in the maintenance of the regulatory database and other regulatory information man-agement lists.
- Is responsible for the maintenance and management of the activity tracking sheets in Live-link
- Identify regulatory opportunities or issues and problems related to designated prod-ucts/projects and recommending solutions
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Candidate Profile:
Ideal Background (State the minimum and desirable education and experience level)
Education:
- A scientific degree in an appropriate biomedical subject (e.g. Pharmacy, Pharmacology, Chemistry, Biology, Medicine, etc.) is required
Languages: - Excellent knowledge of written and spoken English
Experience: - A minimum of 5 years work experience with Pharmaceutical Regulatory Affairs.
- Knowledge of worldwide regulatory procedures and requirements.
- Good communication and influencing skills.
- Good cultural awareness and negotiating with customer competencies.
- Need to maintain long term working relationships with internal customers.
- Good adaptability skills.
- Good managerial and interpersonal skills.
Additional Information:
Experience: Min. 5 years
Location: Hyderabad
Education: B.Pharm-Pharmacy, Pharmacology, B.Sc-Chemistry, Biology
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 83134BR
End Date: 20th Oct., 2011
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