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Principal Regulatory Affairs Consultant - CMC small molecule

Employer
Parexel
Location
United Kingdom;Homeworking
Salary
Competitive
Start date
25 Sep 2024
Closing date
25 Oct 2024
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Discipline
Regulatory Affairs, CMC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval CMC activities. As a recognized professional in your field of expertise, you will utilize your rainmaking skills and extensive knowledge of our consulting models and methodologies to deliver exceptional consulting services to our clients. This is a unique opportunity to showcase your technical skills, specialist knowledge, and mentorship abilities.

This role can be home or office based in various European locations.

Key Responsibilities:

  • Serve as a Project Leader, providing overall project leadership and ensuring the project's successful planning and set-up.
  • Act as the main client contact, maintaining accurate project reporting and delivering to meet client expectations.
  • Develop and implement submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
  • Assess change controls and provide regulatory assessments of quality changes in production and quality control.
  • Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
  • Coordinate submission preparation with various departments, including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
  • Write and review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
  • Collaborate within a team environment to deliver project requirements. Prioritize workloads, both for yourself and the project team, to achieve project scope and objectives.
  • Deliver engaging presentations at seminars and industry group meetings. Author articles for industry publications, demonstrating expertise and showcasing Parexel's capabilities.
  • Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
  • Mentor and coach more junior members of the team.
  • Collaborate with Account Management to prospect and leverage new business opportunities.
  • Effectively communicate Parexel's service offerings, demonstrating our capability to support client needs.


Experience and Skills Required:

  • University-level education in Life Sciences or equivalent by experience.
  • Extensive experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
  • Strong understanding of CMC and post-approval regulatory requirements.
  • Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
  • Knowledge of small molecule processes.
  • Proficient account planning and support abilities.
  • Networking skills to expand professional connections.
  • Team spirit, flexibility, accountability, and organizational skills.
  • Strong project leadership and management knowledge.
  • Strong business acumen for analysis and decision-making.
  • Self-confidence and control in professional engagements.
  • Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
  • Fluent in English (written and spoken).


#LI-REMOTE

Company

parexel

When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

How to describe Parexel’s culture in one word: 

Henry

 

 

Working With Heart™ - Christina's perspective:

Working With Heart™ - Christina's perspective:

 

Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
 Uxbridge
Middx
UB8 1LZ
GB
Apply on website
Send job
Apply on website

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