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 Specialist I / II OTC GRA CMC
Job Purpose (State in one sentence the overall objective of the role)
In line with global category strategies and thru alignment with the global GRA CMC execute global CMC regulatory strategies and activities for the assigned portfolio of projects and products.
1. Responsible for all CMC regulatory matters relating to registrations and maintenance of business activities for assigned product portfolio
2. Interacts with colleagues in other departments, other R&D functions and other Regulatory Affairs functions to deliver high quality dossiers, documents & materials to affiliates in accordance with business priorities. Establish and maintain sound working relationships with partners and customers
3. Supports regulatory affairs teams in the affiliates for all new registrations and variations to assigned projects and products including preparation of responses to Health Authority questions
4. Provides, in close partnership with internal/external authors, all the necessary high quality technical documents for submission for the assigned portfolio of products assuring technical congruency and regulatory compliance
5. Proposes regulatory strategy for assigned portfolio and effectively communicates requirements and guidelines, facilitating timely and complete submissions. Applies systems and procedures necessary to maintain proper records and support adequate controls
6. May contribute to special assigned activities and projects within the team or represent GRA in cross-functional assignments & projects
7. Develop up to date knowledge with regard to guidelines and regulatory as well as technical trends
Education (minimum/desirable): Minimum:
Degree in Science (e.g. Chemistry, Pharmacy, Biology) or equivalent
Advanced degree in Science (e.g. Chemistry, Pharmacy, Biology) or equivalent.
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Languages: Fluent English required (oral and written). Good skills in site (local) language desired (oral)
1. Up to 7 years practical experience (Regulatory, Galenical, Chemical, Analytics or Quality Assurance)
2. Up to 7 years knowledge of global CMC regulatory affairs including experience for CTA/IMPDs, ANDAs, MAAs, INDs, and NDAs
Experience detailed in table below:
3. Working knowledge of chemistry, analytics or pharmaceutical technology. Knowledge of the drug development process and/or over the counter business desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
4. Knowledge/experience of regulations, guidelines for Rx/OTC and product life cycle maintenance desirable.
5. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
6. Effective planning, organizational and interpersonal skills.
7. Reasonable approach to risk assessment.
8. Excellent written/spoken interpersonal communication and negotiation skills.
9. Computer literacy.
Experience: Up to 7 Years
Education: B.Pharm, B.Sc - Chemistry, Biology
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Job Type: Full Time
Employment Type: Permanent
Job ID: 113670BR
End Date: 8th March., 2013
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