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Regulatory Affairs Consultant CMC Biologics

United Kingdom, Remote Date posted 08/10/2022 Job ID R0000001056

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. This role can also be office based or home based in the following countries: Hungary, Belgium, Netherlands, Sweden, Norway, Denmark, Finland , Italy, Spain, Lithuania , Croatia, Poland Czech Republic, Turkey or Romania.

This Regulatory Affairs Consultant - CMC (Biologics) will have an understanding of the organization’s consulting models and methodologies, as well as a good knowledge of what services the group provides. You must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. You will also ensure the timely 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 work independently delivering services within their technical area of expertise
- Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts
- Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes

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

Business Development
- Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience
- Communicates potential new business leads to PC management and account managers
- May participate in project scoping calls and/or proposal preparation with 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. 

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!


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