Regulatory Consultant

JOB RESPONSIBILITIES

• Should have min 4-5 yrs of experience in regulatory affairs 

• should have Mpharm degree

• Should have experience of CMC module 3 , authoring of CMC sections of Post Approval variations and life cycle management activities

• Should have in EU, GCC mkt experience.

For non-complex and complex submissions, independently fulfill the following responsibilities:

• 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 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.

• 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

• Master's degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/medical device related experience.

• Demonstrated experience in contributing to the preparation of regulatory submissions including, for example 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.

• 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.