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 ,Sweden, Norway, Denmark, Finland, Croatia, Poland Czech Republic or Romania.

This Senior /Regulatory Affairs Consultant - CMC - Biologics (level will be dependent on amount of experience)will have an understanding of the organization's consulting models and methodologies, aswell as a good knowledge of what services the group provides. You must have strong technical skills andmay be developing specialist knowledge of a particular subject and/ or market. You will also ensure thetimely performance of work within a project scope to the quality expectations of the group and the client.

You must be capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME. You will contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory submissions throughout the product life cycle (IND, IMPD, NDA, MAA). You will work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data and be prepared to and coordinate the review and approval of submission-ready documents. You will then ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations.

Key Accountabilities:

Project Execution
- Typically works within a team environment but may workindependently delivering services within their technical area ofexpertise
- Works within broad project guidelines but liaises closely with moresenior colleagues to discuss issues and resolve conflicts
- Demonstrates ability to prioritize work and define steps needed toachieve specified project outcomes

Consulting Activities and Relationship Management
- Follows and implements the organization's consulting models andmethodologies
- Provides technical and/or business consulting services withinpersonal area of expertise
- Completes assigned activities within project scope and objectives withan understanding of issues which may impact project profitability
- Collaborates with colleagues and client to identify and resolvetechnical and process issues

Business Development
- Continue to build a network of industry colleagues throughrelationships formed during project engagements or through otherindustry experience
- Communicates potential new business leads to PC management andaccount managers
- May participate in project scoping calls and/or proposal preparationwith the support of senior colleagues

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.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

Experience:
- Previous experience working in CRO, Pharma or a Regulatory agency in the capacity as Regulatory Affairs Consultant or Senior Regulatory Affairs Associate with a strong focus on CMC and particularly Biologics.
- Thorough understanding of change management processes and regulatory requirements
- Good understanding of CMC lifecycle maintenance activities across EU and ROW markets
- Change Control assessment experience (application of relevant regulatory guidance to proposed change)
- CMC Submission experience of Simple (Type I) and complex variations (Type II) to EU markets in the CP, MRP and NP procedures. Experience working on simple and complex APAC and LATAM submissions would be of benefit.

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.