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Senior Consultant (Ireland)

Dublin, Leinster, Ireland Date posted 10/15/2019 Job ID 55159BR

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

Key Requirements & Responsibilities will include some of the following:-
• The successful candidate will be a seasoned professional with extensive hands-on experience with the EU regulations and Guidance.
• The candidate will be able to work US business hours up to 2 pm EST, with occasional later meetings.
• The individual will be results-oriented with concerns for quality and collaboration.
• Responsibilities of this position will include working directly with the project teams to provide regulatory tactical support and strategy for the development, registration, and life-cycle management for products for EU (e.g. MAA development and submission, Variations development and submission, Scientific Advice Procedures & Meetings, and interactions with PDCO).
• The individual will have project management experience, with the ability to understand and contribute to MS Project plans.
• Teams with Clients’ Global Regulatory Lead to:
* Ensure local execution of global regulatory strategies and support the development and execution of Regulatory team’s goals
* Assists in the coordination and compilation of and provides regulatory guidance for all submissions to the EMA ensuring submission documents are accurate, compliant, and high-quality
* Provide appropriate advice and guidance for the development of regulatory correspondence and review and provide expert opinion on the content of regulatory documents, including PIP, RfM, meeting briefing packages, response to Day 120 & 180 questions, etc
* Assists in the management process for responding to regulatory agency questions
* Support all activities for the preparation and conduct of meetings with the European Authorities
* Actively support regulatory compliance of project teams
* Provide regulatory recommendations to support investigational and marketed products

Additional Responsibilities:-

• Supporting EU procedures such as MAA, variations, renewal, PIP’s & Scientific Advice
• Support with strategy, understanding legislation & explaining this to some of the US folks as much as the EU folks.
• Updating SmPC/PL
• Managing and supporting global MS project plans
• SME QC submissions package, Technical and published output
• Experience in Swiss, Canadian MAA submissions & NDA’s

In addition, 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.
* develops specialist knowledge of a particular subject matter or market.
* provides a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives.
* serves either as an individual contributor, a work stream lead or provides overall project leadership.
* 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.

Qualifications

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
• 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

Essential Minimum Requirements:-

* Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred.
* Extensive years of experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a strong advantage. Ideally the successful candidate should be an experienced EU regulator (at least 10 years, preferably more).

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