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