Senior Regulatory Affairs Associate - Generalist
Dublin, Ireland | Parexel
Industry:Pharmaceutical / Biotech
Job Description:60 people have viewed this job
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 a Senior Regulatory Affairs Associate - Generalistyou will have good technical Regulatory Affairs skills and may be developing specialist knowledge of a particular subject and/or market. In this role, you will ensure the timely completion of work within a project scope and to the quality expectations of the client. You will have a good understanding the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Consulting provides.
In this role you will carry out:
- Preparation & submissions of regulatory files
- Communicate with Regulatory Operations on the planning of marketing applications and post-approval supplements and variations
- Coordinate the review and approval of submission-ready documents
- Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations
- 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
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
- 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.
- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
- Moderate project management knowledge
- Strong 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 or 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
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.
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