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Senior Regulatory Affairs Consultant (UK) (CMC Expert)

United Kingdom - Any Region - Home Based Date posted 04/09/2019 Job ID 52023BR

As part of PAREXEL Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of PAREXEL Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

  • Full Time
  • Level: Mid
  • Travel: Yes
  • Glassdoor Rating 3.5

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "They say if you are passionate about what you do, you will never work a day in your life. I can honestly say that this applies to me. I love what I do."

    Jasen - Consultant
  • "My experience so far with PAREXEL has been great! I had initially started at PAREXEL as an Independent Consultant but was then presented with a full time job opportunity to really become a part of this fascinating company. I have enjoyed the flexibility to be able to orchestrate a good work/life balance, as well as learn from so many experts in consulting arena and really have a hands-on role with every day bringing a new but exciting challenge."

    Aqip – Consultant
  • "I was offered an incredible opportunity to continue my career in regulatory affairs without relocating 1,000 miles away and making major life changes. PAREXEL is an innovative, growing company which offers much needed flexibility and opportunities for professional growth."

    Blaine – Consultant
  • "PAREXEL is a very large organization and holds a top position amongst the different companies engaged in the Consulting business. It can offer many opportunities for development and career progression. Also the diversity of projects can offer a great expansion of knowledge in many areas of the Regulatory Affairs arena. Last (but not least), PAREXEL offers a variety of rewards to the employees (bonus scheme, benefits etc)."

    Giannis – Consultant
  • "PAREXEL is a CRO that I had always inspired to join because of the variety of knowledge, experts, culture, flexibility and exposure to be client facing as well as to use my technical knowledge all under a professional and diligent environment. I believe it has provided me the right platform to grow both professionally and individually with the opportunities to present my views and to dialogue with colleagues and clients with all but positive outcomes."

    Aqip – Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

Job Description

Overall Job Purpose:
* A Senior 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 PC provides.
* Is responsible for developing specialist knowledge of a particular subject matter or market.
* Senior Consultants provide a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives.
* As a Senior Consultant, one also serves either as an individual contributor, a workstream lead or provides overall project leadership.
* Senior Consultants provide guidance to project team members on technical/process issues as well as ensures the timely performance of work within a project scope to the quality expectations of PC and the client.
* A Senior Consultant anticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision makers.

Key Accountabilities Include some of the following:-

* 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, responsible for providing overall project leadership

* Consulting Activities & 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

* 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

* 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 management
• Defines self-development activities to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)
• May participate in thought leadership activities (i.e. present speeches or seminars to industry groups and/or author articles.)

Qualifications

Qualifications:-

The Senior Consultant must have sound CMC Regulatory expertise.

Knowledge and Experience:
• Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a strong advantage

Key Skills & Competencies:-
• 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
• Client-focused approach to work
• Results orientation
• Teamwork and collaboration skills
• Proficiency in local language and extensive working knowledge of the English language
• Networking
• Business analysis
• Self-confidence and control

Education:
• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

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