Regulatory Consultant (CMC-EU, GCC & AU)

5264 Syneos Health India Private Limited; Angul; Hybrid; INR 1,200,000 - 1,800,000; Full time

Job summary

Syneos Health India Private Limited is seeking a Regulatory Consultant (CMC-EU, GCC & AU) to own CTD sections, interpret data, and prepare regulatory submissions across the IND, pre-approval, and post-approval lifecycle. The role requires strong CMC authoring and cross-functional collaboration with analytical, formulation, and manufacturing teams.

The candidate will work on submissions across EU, US FDA, AU, GCC, and ROW regions, ensuring compliance with global regulatory requirements and client

Qualifications

• CMC authoring exposure with CTD Module 3 (M3) sections independently.
• Experience with post-approval variations/supplements.
• Cross-functional interaction with analytical, formulation and manufacturing teams.
• Experience across EU, USFDA, AU, GCC, ROW.

Responsibilities

• Own CTD sections and interpret technical data.
• Writes content from raw CMC documents.
• Defends content in authority queries.
• Prepare regulatory submissions for IND, pre-approval packages, product registrations, and post-approval maintenance.

Skills

CMC authoring

CTD Module 3

Cross-functional collaboration

CMC writing

Job description

Regulatory Consultant (CMC-EU, GCC & AU)

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.

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

Mandatory Skillsets: CMC authoring exposure, authored CTD Module 3 (M3) sections independently. Anyone only compiling/reviewing documents will not fit. Experience with post-approval variations/supplements. Cross-functional interaction with analytical, formulation and manufacturing teams. CMC writing and lifecycle management for small molecules. Experience across: EU, USFDA, AU, GCC, ROW. (Not all)

Candidate should:

• Own CTD sections
• Interpret technical data
• Writes content from raw CMC documents
• Defends content in authority queries
• Knows section numbers and expectations

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.
• 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.

Who we are

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment or patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.