Senior Regulatory Affairs Consultant CMC Biologics - Open to EU Locations

We are recruiting for a Senior Regulatory Affairs Consultant - CMC , who will have Expertise in CMC Biologics for regulatory submissions throughout product life cycle. Experience of project leadership, good communication skills and ability to work in team or independently is essential.

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.

Key Accountabilities:

•Develop submission plans and contribute to the execution of timely and innovative regulatory strategies in support of global development and life cycle management of assigned projects

•Collaborate with Global RA CMC lead and/or Regional RA CMC lead to provide regulatory support for assigned projects

• Communicate with Regulatory Operations on the planning of global Clinical Trial Applications, marketing applications and post-approval supplements and variations

• Contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, NDA, BLA, MAA)

• Prepare and coordinate the review and approval of submission-ready documents

• Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations

• Review submission documents to ensure messaging is clear and consistent within and across documents, and to perform a final copyediting check

• Work collaboratively with RA CMC colleagues and SMEs to interpret and summarize complex data

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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