Job
Description
Description Sr Regulatory Consultant (Biologics/Biosimilars) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. 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 accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE 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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Primary Skills required Responsible for authoring and review of CMC sections of regulatory submissions, including Modules 2 and 3, for INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses. Developing, reviewing, and ensuring the completeness of CMC sections within IND and IMPD applications. Ensure all documents are authored in accordance with regulatory guidance (FDA, EMA, ICH). Good understanding of analytical method development, validation, comparability and biosimilarity assessments, upstream and downstream process development. Provide peer review and mentorship to junior writers or team members, ensuring consistency and scientific accuracy across deliverables. Experience with post-approval changes, tech transfers, and product lifecycle management. Excellent written communication, scientific writing, and document organization skills. Stay current with evolving regulatory expectations and industry best practices related to CMC submissions for biologics and biosimilars. Secondary Skills required Deep understanding of CMC regulatory requirements for biologics/biosimilars, including ICH and region-specific guidance. Experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics. Qualifications Minimum 8 years of experience required for CMC-Biologics along with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences. Ability to work independently and manage multiple priorities in a fast-paced consulting environment. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance 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.
