Regulatory Consultant (CMC/ EU Market Exp)

Role & responsibilities

• Demonstrated experience in authoring and review of

  Module 3 CMC sections for post-approval CMC variations,

  renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines

• Strong experience in assessing the change control

  issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy.
• 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-today 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 companys 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.
• Participate as regulatory support on internal cross-functional initiatives.
• Contribute to the creation and/or maintenance of SOPs and other process related documentation as required.
• Provide support in oversight to team members in the execution of their project responsibilities.
• Capable of identifying when to ensure line support required to provide additional guidance and direction.
• Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

QUALIFICATION REQUIREMENTS

• Should have 5+ years total work experience and 4+ years relevant experience in Regulatory Affairs.

• Should have markets experience in EU (mandatory) , GCC (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates) , MEA

• MS, M.Pharm or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory. Moderate pharmaceutical/medical device related experience.
• Demonstrated experience in contributing to the preparation of regulatory submissions including, for example post-approval CMC variations, IND, PMA, NDA, MAA, and CTD, including electronic submissions.
• 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.
• Good quality management skills.
• Advanced skills in Microsoft Office Applications.
• Strong experience in handling Veeva RIMS and TrackWise along with other RIMS systems, would be preferred.
• Ability to interact with staff from multiple departments and offices to establish project standards.
• Good initiative, adaptability, and pro-activity.
• Strong analytical skills, good attention to detail.
• Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
• Fluent in speaking, writing, and reading English.