Regulatory Manager (CMC and Biologics)

Syneos Health, Inc.; India; Vor Ort; INR 3.500.000 - 5.500.000; Vollzeit

Zusammenfassung

Syneos Health in India is seeking a Regulatory Manager (CMC and Biologics) to lead regulatory activities for biologics, biosimilars and CMC programs, including IND and dossier planning with global health authorities.

You will manage project teams, provide strategic regulatory advice, and coordinate submissions, renewals, and lifecycle maintenance, with strong expertise in Module 3 authoring and regulatory documentation.

Qualifikationen

• Min of 10+ years of biologics and CMC experience.
• Strong regulatory intelligence across global markets.
• Hands-on experience in IND writing and product registration dossiers.
• Experience in pre- and post-licensing regulatory activities.
• Familiar with CMC variations, amendments and renewals.

Aufgaben

• Contributes to planning for regulatory submissions in assigned region/country/project.
• Manages day-to-day project teams and staff responsibilities including mentoring and performance management.
• Represents Regulatory in cross-functional meetings and with health authorities.
• Supports business development with regulatory insights and proposal input.
• Writes INDs and product registration dossiers and oversees regulatory documentation.

Kenntnisse

Biologics

CMC

Regulatory Intelligence

Module 3 authoring

Dossier preparation

Regulatory submissions

Lifecycle management

People management

Client liaison

Strategic regulatory advice

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. 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

• 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 a