Regulatory Affairs Consultant - CMC author biologics (home or office based)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel is seeking experienced CMC (Chemistry, Manufacturing, and Controls) professionals to join us as a Regulatory Affairs Consultant CMC Author to support   our   client. This position requires expertise in regulatory affairs, CMC   authoring for initial submissions and   lifecycle management, and   other   pharmaceutical documentation for   biologics . Previous experience working with biologics products is a must.

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

Role Responsibilities   :

• Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance.  

• Thorough understanding of global regulations and ICH guidance pertaining to pharmaceutical development and lifecycle management of NCE/NME products.  

• Experience preparing CMC sections of IND/IMPDs, BLA/NDA/MAAs, and supportive clinical amendments and post approval supplements/variations. (ICH Modules 2 and/or 3)  

• Write scientific rationales to support regulatory answers, variations, and dossier submissions  

• Coordinate CMC activities across multiple projects and manage timelines effectively  

• Thorough understanding of change management processes and regulatory requirements.  

• Build and assess regulatory strategies for variations and registrations based on affiliate information and EU/US guidelines  

• Develop regulatory strategy for medical devices part of combination products  

• Update and maintain database with current regulatory information  

• Provide ad-hoc CMC consulting support and technical advice   

Required Qualifications & Skills  

• University degree in Chemistry, Pharmacy, Chemical Engineering, or related pharmaceutical field  

• 10+ years of pharmaceutical industry experience in CMC and regulatory affairs  

• Strong expertise in CMC for biologicals   – initial submissions and Lifecycle maintenance  

• Comprehensive understanding of ICH guidelines and EU/US regulatory guidelines

• Strong problem solving and diplomacy skills

• Ability to manage multiple projects simultaneously and meet deadlines  

• Experience with   Veeva   or similar document management systems

• F luent English (written and spoken); Additional European languages (French, German, Spanish) are advantageous