Regulatory Affairs Manager

• Preparation Review and submission of Technical documents/Dossiers (CTD/ACTD) for Regulatory and Non Regulatory Markets Publishing electronic regulatory submissions (eCTD).
• Submission build activities creating interdocument links performing quality checks and validating compiled submissions and finalizing submission by required dispatch date.
• Coordinate & engage with RA Ops team for timely submissions / Publishing tasks.
• Reviewing manufacturing documents like MFC BMR process validation Protocol/report stability protocol/report sampling protocol process validation protocol and PDR.
• Create monitor and maintain timelines for client strategic development submission management and regulatory affairs programs.
• Develop and execute on global strategic plans (regulatory and/or quality systems) for the development of client medical device development programs Act as subject matter expert in certain areas of EU MDR / IVDR
• Establish and direct crossfunctional teams of internal and external personnel to deliver client projects.
• Support Regulatory Operations / Submission management Automation / IT efforts
• Provide training for inhouse personnel and supervise the assigned Regulatory staff as needed.
• Participate in meetings with regulatory authorities
• Monitors activities of applicable regulatory agencies and industry organizations to identify any changes in regulations and communicate to appropriate personnel.
• Shows an understanding of the changing regulatory environment and the impact on business practices policies and projects and demonstrates an ability to discuss relevant points in a diverse forum in more general terms.

• Directly supervises employees assigned. Carries out supervisory responsibilities by the organizations policies and applicable laws.
• Responsibilities include interviewing hiring and training employees; planning assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Manages applicable portions of established departmental budget using good judgment to ensure that costs are appropriate and reasonable and that any foreseen overages are communicated for transparency.

• Any Bachelor/Master in Any Life Science with a Minimum 712 years of experience within CRO / Biotech / Biopharma industry.
• Gap Analysis Handson experience in publishing and Knowledge on CTD compilation
• The ability to deal effectively with sponsors and internal customers at all levels.
• Excellent communication and interpersonal skills both written and spoken.

regulatory affairs,publishing,electronic common technical document (ectd),regulatory submissions