Associate, regulatory affairs
1 month ago
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 requirements.
KEY RESPONSIBILITIES
Provides 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 systems
Liaises 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 specialist
Evaluates and ensures that submissions are accurate and meet format and content requirements as per Health Canada regulations, completing dossier publishing using e CTD software
Completes 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 supply
Contributes to an efficient and effective regulatory affairs team and uses knowledge and expertise towards a culture of continuous improvement
Maintains 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 data
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner
Knowledge of GMP requirements and QA/QC procedures
Strong understanding of Health Canada and ICH regulatory guidance documents and policies
Proficient computer skills, including MS Office applications and Adobe Acrobat; Experience with e CTD publishing tools is an asset
Demonstrated understanding of sterile product manufacturing is preferred
QUALIFICATIONS
University 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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