CMC Regulatory Affairs Associate (M3 Authoring experience for Biological product

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.

Join Our Growing Team of CMC Regulatory Professionals!

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, and 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. A degree in biological or health sciences (Regulatory Affairs preferred) and at least 5 years of experience in CMC regulatory affairs within the biotech or pharmaceutical industry are essential.

Activities:

• Conduct and deliver high quality, on time CMC regulatory activities, including compliant management of all internal tools and client systems;
• Author Administrative and CMC regulatory documents/deliverables and collaborate 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), create submission binders and Global Content List/Submission Content Plans, coordinate the publishing aspect, review of eCTD sequences;
• Act as main GRA point of contact for LRAs and other stakeholders (i.e. for responding to any queries)
• Excellent communication and stakeholder management skills;
• Strong organizational and time management skills;
• Strong problem-solving skills;
• Coordinate all assigned activities;
• Ensure compliance to all client SOPs/training sessions;
• Proactive’ and ‘efficient' work ethic; Strong oral skills, with proven ability to work efficiently as part of a team;
• Strong interpersonal skills.

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

Experience:

• 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

This role offer 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.

Originally posted on Himalayas