Job Description

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. This role can also be office based or home based in the following countries: Hungary, Italy, Spain, Lithuania , Croatia, Poland Czech Republic or Romania.

As the Senior / Regulatory Affairs Consultant -RoW/Emerging Markets(level dependent on experience) you 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 we provide. You will develop specialist knowledge of a particular subject matter or market. You will also provide a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives. You will also serve as either an individual contributor, a workstream lead or provide overall project leadership and guidance to project team members on technical/process issues.

You will be the expert who can provide strategic guidance to our clients and our delivery teams on requirements and submissions, including submissions of new product applications, across international regions.

Key Accountabilities:
- Creating and performing regulatory intelligence surveys, providing an objective assessment of intelligence data, communicating regulatory requirements, and proposing submissions strategies to clients.
- Ability to develop International Regulatory Submission Strategies to meet client needs for a wide variety of products/projects.
- Supporting Project leads in working local market Regulatory Affairs experts to optimise strategies for specific submissions
- Guiding delivery teams in the creation of International dossiers
- Identifying and mitigating risk with respect to international submissions
- Ensuring effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements.
- Coaching, mentoring and leading regulatory teams to ensure objectives are successfully delivered to time and quality.
- Monitors and keeps abreast of key changes in the regulatory environment of International markets; support and advise accordingly.
- Broad background in pharmaceutical business and experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
- Demonstrations of and management experience.Qualifications

Education:
- 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
- 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

Knowledge and Experience:
- Extensive experience in an industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus
- Previous CRO / Pharma or Regulatory Agency experience acting in the capacity of a Regulatory Affairs Consultant or Senior Regulatory Affairs Consultant
- Client-focused approach to work
- Regulatory Lead experience
- Strong experience supporting submissions in these regions, particularly with emerging markets.
- An in depth knowledge of international requirements for regulatory affairs is critical for success in this role.

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!Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.