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 tot his job