Job Description

Job Description

Job Title Manager (US & Canada)
Department Regulatory Affairs
Educational Qualification M. Pharm.in Pharmaceutics from a reputed university
Experience Approx. 5 years experience in one or more:
Pharmaceutical Manufacturing, Quality Control, Formulation Development, Analytical Development, Technology Transfer & Validations
At least 5 years of regulatory exp. in US, Canada
Location Gurgaon
Description
RESPONSIBILITIES:
Manage all aspects of the regulatory process for US and Canada submissions, viz, review and submission of the marketing authorization application, timely and satisfactory response to the deficiency letters
To prepare and co-ordinate the submission of supplements, drug listing, renewals, etc.
Manage a team that consists of several regulatory affairs personnel
Participate in product teams with regard to implementation of regulatory requirements.
Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning.
Provide regulatory expertise to analytical and formulation development teams and ensure that information is interpreted correctly.
Review of the technology transfer documents with regards to US and Canada specific requirements.
Handling of change controls.
Maintain a working knowledge of regulatory requirements and guidelines and communicating changes in regulatory information to the team members.
Update licensing and collect information on registration instructions and regulations.
Maintain database of FDA-approved and marketing approved drugs.
Flexibility to work for other regions, based on internal requirements, if required.

TECHNICAL EXPERIENCE:
Must have thorough understanding of USFDA and Health Canada regulations and pertinent state and federal laws governing pharmaceutical products.
Careful delegation of tasks whilst maintaining responsibility for final result.
Careful planning to achieve accurate and timely results.
Ability to discuss strategic and sensitive issues.
Recognise recurring issues and analyse their causes in order to reach a solution.

PERSONAL ATTRIBUTES:
Good communication skills.
Be proactive in taking responsibilities
Have good planning and organizing capabilities
Have good inter-personal relationships


 

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