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Senior / Regulatory Affairs Associate - CTA

Dublin, Leinster, Ireland Date posted 06/16/2022 Job ID 82777BR

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.

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
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs 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

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. 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 Associate (depending on level of experience) you will have and develop knowledge of the organization’s basic consulting models and methodologies as well as basic knowledge of what services the group provides. You must be technically competent and continually developing the skills as defined in the key accountabilities section . You will also under the general direction of a Project Lead or Technical SME, take responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the group and the client. The guidance of more senior staff may be needed to accomplish more complex tasks. You may also act in a client facing role with clear guidance and support from line management.

Key Accountabilities:

Project Execution
- Works effectively within a team environment
- Works within broad project guidelines as directed by the Project Lead or Technical SME
- With the guidance of the project Technical SME, demonstrates the ability to prioritize work to achieve specified project outcomes
- Capitalizes on opportunities to improve one’s own performance and seeks feedback from the Project Lead and colleagues

Consulting Activities and Relationship Management
- Follows and implements the organization’s consulting models and methodologies under the guidance of the project lead and/or Technical SME
- Delivers a limited range of consulting services within personal area of expertise under the guidance of the Project Lead and/or Technical SME
- Completes assigned activities within project scope and objectives under the direction of the Project Lead and/or Technical SME

Business Development
- Begin networking within the industry (i.e. maintain contacts and relationships with clients once engagements are complete)
- Communicates potential new business lead to PC management and account managers

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, training compliance, project deliverable archiving, participation in internal initiatives/projects
- Defines self-development activities with the support of management in order to keep current within the industry.

Qualifications

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

Skills:
- Project management knowledge
- Client-focused approach to work
- Results orientation
- Teamwork and collaboration skills
- Consulting skills
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Critical thinking and problem-solving skills
- Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience:
- Basic experience in a CRO industry-related environment; experience with a regulatory agency (such as MHRA) is a plus
- Previous CRO or Pharma experience acting in the capacity of a Regulatory Affairs Associate or Junior Regulatory Affairs Associate would be desirable.
- Client-focused approach to work (Quality)
- Regulatory CTA / MAA submission experience for the UK & Ireland.

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 and benefits package including days holiday and other leading edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!

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