Regulatory Consultant

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

About the role

Provide regulatory and technical support for assigned product development projects, including product development documents and regulatory agency submissions, implementing/managing project regulatory activities, and supporting clients and project teams.

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-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.
• 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.

Requirements

• Minimum 4-5 years of experience in regulatory affairs.
• M.Pharm degree.
• Experience with CMC module 3, authoring of CMC sections of Post Approval variations and life cycle management activities.
• Experience in EU and GCC markets.
• 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.

Skills

• Excellent interpersonal and communication skills, including written and verbal communication.
• 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 and 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.

About Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to building an inclusive culture where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.