Senior Executive - Regulatory Affairs
Sun Pharmaceuticals, Inc, Indiana, PA, United States
Job Title
Executive Regulatory and Business Continuity
Business Unit R&D1 Regulatory Affairs
Job Grade G12A
Location Baroda
Key Responsibilities
Preparation & submission of API DMF Open & closed part as per market requirement (Brazil, China, CIS, Asian, Middle east & Africa etc.).
Preparation & submission of query response to authority.
Handling of Post approval change evaluation & submission as per country requirements.
Response to customers request, query & other documents.
Review of Plant, RnD data required for submission.
Collaboration & coordination with RA team & cross functional teams (Plant, RnD, marketing etc.)
Travel Estimate NA
Job Requirements Educational Qualification MSc / M. Pharm
Experience Tenure: 1-3 yrs.
Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
Equal Employment Opportunity Statement We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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Business Unit R&D1 Regulatory Affairs
Job Grade G12A
Location Baroda
Key Responsibilities
Preparation & submission of API DMF Open & closed part as per market requirement (Brazil, China, CIS, Asian, Middle east & Africa etc.).
Preparation & submission of query response to authority.
Handling of Post approval change evaluation & submission as per country requirements.
Response to customers request, query & other documents.
Review of Plant, RnD data required for submission.
Collaboration & coordination with RA team & cross functional teams (Plant, RnD, marketing etc.)
Travel Estimate NA
Job Requirements Educational Qualification MSc / M. Pharm
Experience Tenure: 1-3 yrs.
Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
Equal Employment Opportunity Statement We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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