Senior Regulatory Affairs Associate / Regulatory Affairs Consultant, FSP (Genera

We are seeking an experienced Regulatory Generalist to join our FSP team as a Senior Regulatory Affairs Associate / Regulatory Affairs Consultant to work closely with one large, dedicated client and provide operational support in the IND / NDA maintenance stage.

The Sr. Associate / Consultant will also provide appropriate regulatory guidance to Project Teams for the development of regulatory submissions and be responsible for the overall quality of submissions;

manages, reviews and organizes documents intended for submission to FDA to assure compliance with regulatory standards.Additionally, a Sr.

Associate / Consultant must have a comprehensive understanding of the organization's consulting models and methodologies, as well as profound knowledge within a business context of what services Parexel Regulatory Consulting provides.

Provides a broad range of consulting services and works within broad project guidelines to identify, refine, and address client issues and to achieve project objectives.

Provides guidance to project team members on technical / process issues.

Ensures the timely performance of work within a project scope to the quality expectations of PC and the client.

Anticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision makers.

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.

Prioritizes own workload and may prioritize the workload 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 Parexel and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and Parexel are met.

Manages small projects and may manage larger project engagements.

Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support.

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.

Develops 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 the 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 with Parexel Regulatory management and account management.

To ensure success, we are looking for individuals that have :

3+ years' experience in an industry-related environment; Pharmaceutical / Biotechnology, CRO, or Life Science Consulting industries.

Previous CRO experience is a plus.

3+ years of experience in General Regulatory Affairs with previous experience in the preparation of IND, CTA, MAA, NDA submissions to include reviewing and / or writing sections of applications from a clinical, nonclinical, or CMC regulatory perspective.

The level and depth of experience will determine a Sr Associate / Consultant level role.

Submission and maintenance of official local drug information, including Patient Information Leaflets, USPI, SmPCs, packaging texts, RMPs and their Educational Material.

Review, preparation and filing of post- approval license variations / amendments.

Assists senior RA team members with new NDA / MA submissions eg Scientific Advice meetings, attendance at launch meetings, pre-vetting materials and stock readiness.

Previous small molecule experience is highly preferred.

Knowledge of FDA and EMA processes and regulations

Familiarity / experience with FDA and EMA interactions (verbal or written) is required.

Experience with project lifecycle and management

Medical device experience is a plus.

Please note, the ideal candidate should have experiences including pre / post approval submissions, INDs, aggregate reporting, etc.

in both US and EU territories and be able to flex to attend meetings during US core hours as required.

Education - Minimum of a Bachelor's Degree in a Scientific or Technical Discipline; Advanced Degree PreferredLanguage Skills - At least fluent vocal and written English

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

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