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Senior Regulatory Affairs Consultant- CMC Biologics
Primary Location: India, Remote Job ID R0000038656 Category Regulatory Affairs Date Posted 02/27/2026Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
Senior Regulatory Affairs Consultant- CMC Biologics
10+ years of experience in handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia.
Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.
Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
Strong communication and collaboration skills, ability to work independently.
Project Execution
Works within a team environment or individually based on the project needs
Works within broad project guidelines and facilitates issue and conflict resolutions
As a Project Leader, provides overall project leadership:
Responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.)
Functions as the main client contact and ensures accurate project reporting is in place
Ensures that the project team delivers to meet the client expectations for quality and timeliness
Ensures that appropriate risk identification and issue-escalation procedures are in place, and leads issue and conflict resolutions
Ensures project specific training compliance of the project team
Manages project financials including provision of accurate revenue forecasts
Ensures that the project team understands and works to the scope of the contract
Identifies new opportunities through Change in Scope (CIS) or add-on business from existing work
Ensures timely project close-out activities are completed
Prioritizes own work load and may prioritize the work load of the project team in order to achieve the project scope
Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
Leverages information from previous projects or other client work to complete assigned project activities as well as facilitate business decisions
Produces quality work that meets the expectations of PC and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met
Provides guidance to project team members, and acts as a mentor to junior staff
Consulting Activities and Relationship Management
Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements
Provides a full range of technical and/or business consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear
Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction
Facilitates client decision making by framing issues, presenting options and providing objective business advice
Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities
Acts as a trusted advisor to clients and/or project team on technical and/or process issues
Supports development of business solutions addressing specific client needs using best practices and knowledge of the client’s business and key industry drivers
Interacts professionally at multiple levels including senior management within a client organization
Successfully penetrates executive management levels or other business units within a client organization
Facilitates clients in identifying and addressing their needs and develops processes and solutions to address issues before they become significant problems
Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referrals
Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account management
Business Development
Maintain and continue to grow a network of industry colleagues through relationships formed during project engagements or through other industry experience
Actively participates in project scoping calls and proposal preparation
May deliver sales presentations and participate in bid defense meetings when needed
Contributes information to support the account planning process and integrated marketing programs
Contributes ideas for approaches to new clients or new service offerings
Education:
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree preferred
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