Senior Regulatory Affairs Consultant - RCS

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

This role can be either office based in Uxbridge or Dublin or you can be fully home based anywhere in the UK or Ireland respectively. This role can also be office based or home based in the following countries: Hungary, Belgium, Netherlands, Switzerland, Italy, Spain, Lithuania , Poland, Sweden, Norway, Finland, Denmark Czech Republic , Serbia, Croatia or Romania. The offices are open planned and you will be working in an innovative and collaborative environment connecting with colleagues from around the world.

As the Senior Regulatory Consultant in RCS, you will have a comprehensive understanding of the organization’s consulting models and methodologies, as well as a profound knowledge within a business context of what services we provide to our clients.

You will also develop a specialist knowledge of a particular subject matter or market as well as providing a broad range of consulting services and work within project guidelines to identify, refine, and address our client issues and achieve project objectives.

Finally you will act as either an individual contributor, a workstream lead or provide overall project leadership by providing guidance to project team members on technical/process issues and anticipating our next client need and qualifies opportunities with key decision makers.

Key Accountabilities:

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

- 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.)

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

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 and may deliver sales presentations and participate in bid defense meetings when needed

Parexel related Responsibilities

- Meets established metrics as specified in scorecard on an annual basis

- Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by managementQualificationsEducation:

- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

Skills:

- High-level consulting skills

- Critical thinking and problem-solving skills

- Project leadership and management knowledge

- Excellent interpersonal and intercultural communication skills, both written and verbal.

- Proficiency in local language and extensive working knowledge of the English language. If English is a second language, must be fluent both verbally and in written communication. A second language is an advantage, but not essential

- Client-focused approach to work

- Results orientation

- Teamwork and collaboration skills

- Networking

- Business analysis

- Self-confidence and control

Knowledge and Experience:

- Previous CRO / Pharma / Regulatory Agency experience acting in the capacity of a Senior Regulatory Affairs Consultant or Principal Regulatory Affairs Consultant is essential.

- Advanced experience with expert level regulatory industry or knowledge working with a regulatory agency (such as FDA, MHRA or other EU agencies) is desirable.

- EU Regulatory Subject Matter Expert - familiarity with a broad range of EU regulatory submissions, including Paediatric Investigation Plans (PIPs), orphan designations (EU ODD), EMA and national scientific advice, Marketing Authorisation Applications. Knowledge of US equivalent an advantage, but not essential

- Experience of contributing to EU agency interactions – leading these interactions an advantage (EU, US knowledge an advantage but not essential)

- Experience of preparation and execution of regulatory strategies for assigned products – EU essential, knowledge of US an advantage but not essential

- Ability to author assigned clinical/regulatory documents to support submissions e.g. IMPD sections, CTD sections (clinical, M1), PIPs, EU ODD, Scientific Advice dossiers.

- Demonstrated ability to work with minimal oversight on assigned tasks, being able to come up to speed in new areas quickly.

- Ability to work across different technical functions and with colleagues at all levels of seniority

- Ability to work on multiple projects, managing own time and ensuring timely client delivery to agreed quality

- Act as a mentor to more junior colleagues and contribute/share experience and knowledge to increase the effectiveness of the consulting group

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus, car allowance (selected countries) and a benefits package including holiday and other leading edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!