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Regulatory Affairs Manager
1 month ago
Direct message the job poster from Rubicon Research Limited Human Resources & Talent Acquisition at Rubicon Research / AdvaGen Pharma / Validus Pharma Job Description Purpose This position will be responsible for regulatory product registration filings in key markets including Canada, UK/EU, and AU, and will also need to support US filings as required. The role will involve compilation of dossiers for filing in key markets, responding to queries from regulatory agencies, interacting with stakeholders, and managing regulatory communications with Health Canada. Position / Job Title : Manager Department : Regulatory Affairs Reporting To : AGM/GM – Regulatory Affairs (Key Markets) Years of Experience : 10-12 years Responsibilities Compilation of dossiers for filings in key markets including Canada, UK/EU, and AU for generic and new products. Responding to queries from regulatory agencies. Coordinate with stakeholders and cross‑functional team for filing documents and data. Manage product registration filings in key markets. Manage communications and meetings with Health Canada. Support (as needed) US filings in the pre‑approval or post‑approval space. Coordinate with global regulatory teams. Ensure business growth and operational excellence within the regulatory set‑up. Qualifications & Pre‑Requisites Proficiency in Regulatory Affairs. Excellent communication, planning, analytical and interpersonal skills. Prior work experience with Health Canada is preferred. Referrals increase your chances of interviewing at Rubicon Research Limited by 2x. #J-18808-Ljbffr
