[Hiring] CMC Regulatory Affairs Associate @Parexel

Role Description

The Senior Regulatory Associate will author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including responses to Health Authority requests. Responsibilities include:

• Preparing and reviewing CMC packages
• Supporting GMP submissions
• Managing change control assessments
• Ensuring compliance with regulatory requirements across multiple regions

The role requires strong technical regulatory expertise, excellent writing skills, and the ability to evaluate scientific CMC information for accuracy.

Activities include:

• Conducting and delivering high quality, on time CMC regulatory activities, including compliant management of all internal tools and client systems
• Authoring Administrative and CMC regulatory documents/deliverables and collaborating with project SMEs and client stakeholders to prepare submission packages
• Full management of CMC submissions (i.e. planning, submission package compilation, RtQ preparation, Spontaneous HA queries, etc.)
• General submission coordination (submissions planning, tracker update, timelines agreement with LRA and GRA-CMC, recurrent meetings with LRAs, creating submission binders and Global Content List/Submission Content Plans, coordinating the publishing aspect, reviewing eCTD sequences)
• Acting as main GRA point of contact for LRAs and other stakeholders (i.e. for responding to any queries)
• Exhibiting excellent communication and stakeholder management skills
• Demonstrating strong organizational and time management skills
• Applying strong problem-solving skills
• Coordinating all assigned activities
• Ensuring compliance to all client SOPs/training sessions
• Maintaining a proactive and efficient work ethic
• Exhibiting strong oral skills, with proven ability to work efficiently as part of a team
• Demonstrating strong interpersonal skills

Qualifications

• University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD); a degree in Regulatory Affairs is advantageous

Requirements

• Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs CMC for Senior and 2 for Associate level
• Experience with biological products - Mandatory - and Vaccines preferable
• M3 authoring experience - mandatory
• Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia)
• Regulatory CMC writing skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements - nice to have
• Knowledge in Good Manufacturing Practice or related areas would be highly regarded
• Experience using Veeva

Benefits

• This role offers exciting opportunities for growth and impact within a collaborative and forward-thinking team environment
• Ideal candidates will be motivated by the chance to shape regulatory strategies, drive successful submissions, and ultimately contribute to bringing important medical advancements to patients worldwide