Regulatory Consultant (CMC Module 3)

Regulatory Consultant (CMC Module 3) 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. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health

• 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.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities Job Title: Regulatory Affairs Consultant / Senior Regulatory Consultant (CMC) Location: Remote Experience: 6–12 Years

Key Responsibilities

Author and review Module 3 (CMC) documentation for post-approval submissions and lifecycle management activities Prepare and support CMC variation applications (EU Type IA, IB, II; US CBE, PAS; ROW variations) Manage site transfer submissions including documentation compilation and regulatory strategy support Collaborate with cross-functional teams (Manufacturing, QA, QC, Supply Chain) for data collection and verification Track and manage assigned regulatory activities to ensure timely submission and compliance Respond to regulatory authority queries/deficiencies effectively and within timelines Participate in client and cross-functional meetings as a regulatory representative Provide technical guidance and troubleshooting support to team members Ensure compliance with project scope, timelines, and budget requirements Maintain effective communication with internal teams and global stakeholders Required Skills & Expertise Strong experience in CMC authoring and review (Module 3) Hands-on experience with post-approval lifecycle management and variations Expertise in EU regulatory requirements (mandatory) and ROW markets Experience in API and Drug Product (DP) related variations Knowledge of eCTD submissions and regulatory tools Strong stakeholder management and communication skills Ability to work independently and manage multiple priorities

Qualifications

M.Pharm / M.Sc. or equivalent Life Sciences degree Get to know 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. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Apply To This Job