Regulatory Consultant, EU Market – Module 3
Job Description:
• Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
• Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance.
• Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.
• Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
• Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
• Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.
• Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
• Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
• Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
• Prepare training materials and share best practices in the regulatory area, both internally and externally.
• Participate as regulatory support in internal or external project audits.
• Contribute to the creation and/or maintenance of SOPs and other process related documentation as required.
Requirements:
• min 4-5 yrs of experience in regulatory affairs
• Mpharm degree
• experience of CMC module 3, authoring of CMC sections of Post Approval variations and life cycle management activities
• EU, GCC mkt experience
• Moderate pharmaceutical/medical device related experience
• Excellent interpersonal / communication skills including excellent written and verbal communication skills
• Excellent customer service skills with the ability to work both as a team member and independently
• Advanced skills in Microsoft Office Applications
• Fluent in speaking, writing, and reading English
Benefits:
• career development and progression
• supportive and engaged line management
• technical and therapeutic area training
• peer recognition and total rewards program
Apply Now
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• Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
• Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance.
• Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.
• Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
• Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
• Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.
• Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
• Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
• Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
• Prepare training materials and share best practices in the regulatory area, both internally and externally.
• Participate as regulatory support in internal or external project audits.
• Contribute to the creation and/or maintenance of SOPs and other process related documentation as required.
Requirements:
• min 4-5 yrs of experience in regulatory affairs
• Mpharm degree
• experience of CMC module 3, authoring of CMC sections of Post Approval variations and life cycle management activities
• EU, GCC mkt experience
• Moderate pharmaceutical/medical device related experience
• Excellent interpersonal / communication skills including excellent written and verbal communication skills
• Excellent customer service skills with the ability to work both as a team member and independently
• Advanced skills in Microsoft Office Applications
• Fluent in speaking, writing, and reading English
Benefits:
• career development and progression
• supportive and engaged line management
• technical and therapeutic area training
• peer recognition and total rewards program
Apply Now
Apply Now