Associate, Regulatory Affairs
1 month ago
Associate, Regulatory AffairsReports To:
Director, Regulatory AffairsLocation:
Hyderabad, Telangana, India
POSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.
KEY RESPONSIBILITIESProvides cross-functional review and strategy from a regulatory, scientific and technical viewpoint.Coordinates the assembly, including requesting and/or generating, of documents to support submissions including generic injectables, and may also include complex generics and biosimilars per established business processes and systemsLiaises with partners to collect documents and information for submission preparation or in response to technical queries/deficiency letters.Builds and maintains a healthy working relationship with business partners.Executes labelling activities, preparing the product monograph and coordinating the generation of mock-up artwork with senior artwork specialistEvaluates and ensures that submissions are accurate and meet format and content requirements as per Health Canada regulations, completing dossier publishing using eCTD softwareCompletes RA impact assessments for change controls as necessary.Communicates effectively with internal departments (Product Development, Quality, Supply Chain, Marketing, etc.) to assist in the continuation of product supplyContributes to an efficient and effective regulatory affairs team and uses knowledge and expertise towards a culture of continuous improvementMaintains current awareness of Health Canada regulatory guidelines and shares knowledge with the department
TECHNICAL SKILLS:Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by dataDemonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical mannerKnowledge of GMP requirements and QA/QC proceduresStrong understanding of Health Canada and ICH regulatory guidance documents and policiesProficient computer skills, including MS Office applications and Adobe Acrobat; Experience with eCTD publishing tools is an assetDemonstrated understanding of sterile product manufacturing is preferred
QUALIFICATIONSUniversity Degree in Science or Life Sciences. Post-graduate certification in Regulatory Affairs program preferred.Must have a minimum of 3 years of experience with drug submissions for Health Canada. Sterile injectable experience preferred.Ability to work with changing priorities that involve multiple and concurrent projects.Excellent oral and written communication skills.Strong understanding of Canadian regulatory guidance documents and policies, as well as ICH and international guidelines.
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hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...
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Associate, Regulatory Affairs
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hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...
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Associate, Regulatory Affairs
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hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...
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Associate, regulatory affairs
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Hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...
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1 month ago
hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...
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Associate, regulatory affairs
1 month ago
Hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...
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Associate, Regulatory Affairs
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Hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, India POSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. KEY...
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Hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, India POSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. KEY...
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hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, India POSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. KEY...
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hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...
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Hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...
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