Regulatory Affairs Associate II job in Princeton
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
The Associate II, Regulatory Affairs prepares and submits regulatory filing documents. Monitors and tracks information and requirement changes. |
Compiles and reviews ANDAs, Amendments, Supplements, Annual Reports, etc. for FDA submissions.
Interacts effectively with functional business units in order to obtain documentation required for submissions
Evaluates changes to regulatory documents via the change control process and formulates strategies to maintain submission goals.
Some interaction with regulatory agencies.
Reviews ANDA labeling documents.
Maintains compliance with regulatory requirements for generic drugs for the US market.
Maintains Regulatory Databases
Identifies potential issues and resolves routine problems.
Performs other duties as assigned.
Adheres to all applicable procedures, cGMPs, company policies and any other
quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA,
ANVISA, etc.)Bachelor's in a scientific related field required
At least three years of pharmaceutical experience and at least one year of regulatory experience preferred.
Computer knowledge, problem solving skills, strong working knowledge of regulatory and drug development processes, strong technical knowledge, innovative and creative, possesses good judgment and leadership ability.
Adherence to all health, safety & environmental requirements in support of
departmental and site HSE goals. Work in a safe and efficient manner.
Good oral and written communication skills
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