Regulatory Manager (CMC and Biologics)

5264 Syneos Health India Private Limited; Hyderabad; Hybrid; INR 3.000.000 - 5.500.000; Vollzeit

Zusammenfassung

Syneos Health is seeking a Regulatory Manager (CMC and Biologics) to lead regulatory strategy and submissions for biologics and biosimilars across global markets. The role requires extensive experience in Module 3, health authority interactions, and lifecycle management.

You will guide cross-functional teams, coordinate IND and product registrations, and ensure compliance with regional regulatory requirements. Strong leadership and communication are essential in this senior role based in India.

Qualifikationen

• BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field.
• Demonstrated experience in regulatory submissions including IND, NDA, MAA/CTD and electronic submissions.
• Fluent in speaking, writing, and reading English; strong interpersonal and communication skills.

Aufgaben

• Contributes to planning for regulatory submissions in assigned region/country/project.
• Manages day-to-day activities of project teams and staff related to regulatory deliverables.
• Writes IND and product registration dossiers, clinical reports, and other regulatory documents; coordinates submissions across global markets.
• Provides regulatory advice and strategic guidance to clients and internal teams.

Kenntnisse

Regulatory Affairs

CMC

Biologics

English proficiency

Ausbildung

BS degree in science or related field

Jobbeschreibung

Regulatory Manager (CMC and Biologics) 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.
• We are continuously building the company we all want to work for and our customers want to work with.

Job Responsibilities Min of 10+ yrs of Biologics + CMC experience Experience in Biologics, Biosimilars, and CMC. Strong expertise in Regulatory Intelligence across various global markets. Hands-on experience in Module 3 authoring and dossier preparation. Knowledge of regulatory submission strategies and compliance requirements. Extensive experience in product lifecycle management. Managed both pre-licensing and post-licensing regulatory activities. Experience in preparing and maintaining regulatory documentation for health authority submissions. Familiar with market-specific regulatory requirements and change management processes. Strong understanding of CMC variations, amendments, and renewals. Open to exploring opportunities in Small Molecules in addition to Biologics and Biosimilars.

Job Responsibilities

• Contributes to planning for regulatory submissions in assigned region/country/project.
• Responsible for day to day management of project teams and projects.
• Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Acts as a representative of the regulatory department with other departments.
• Supports business development, including generation of repeat business from existing clients and proposal development.
• develops, reviews, and monitors project budgets; reviews client invoicing.
• Monitors personal utilization and utilization of direct reports.
• Acts as a key point of contact for clients and regulatory authorities.
• Provides regulatory advice to Company associates.
• Conducts regulatory research on projects as needed.
• Provides strategic and operational advice to clients.
• Arranges, leads, and reports on client and regulatory agency meetings.
• Writes IND and product registration dossiers, clinical reports, and other regulatory documents. Manages project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post approval maintenance activities.
• Acts as a resource for technical knowledge.
• Participates in quality improvement efforts to increase overall operational efficiency.
• Contributes to the building of regulatory systems and infrastructure needed for GRAS.
• Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.
• Develops solutions to complex problems.
• Provides internal training in appropriate areas of expertise to other departments.
• Other Responsibilities: Performs other work-related duties as assigned.
• Minimal travel may be required (up to 25%).

Qualification Requirements

• BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device related experience. Moderate experience in regulatory.
• Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, MAA, and CTD, including electronic submissions. Experience in niche submissions such as ODD, PIP/PMP an advantage.
• Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development.
• 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 and budgeting skills.
• Good people management, project management, problem-solving, and decision-making 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.

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.

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 and 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.