About this role
Parexel
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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
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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
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Experience with biological products - Mandatory - and Vaccines preferable)
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M3 authoring experience - mandatory
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Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia).
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Regulatory CMC writing skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements - nice to have
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Knowledge in Good Manufacturing Practice or related areas would be highly regarded.
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Experience using Veeva
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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.
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Why Consultants work at Parexel
Patient-led in everything we do
We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects.
Supportive and inclusive environment
We thrive on collaboration, caring, and inclusivity - enabling our people to work together to solve complex problems and share knowledge.
Opportunities for career growth
We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, providing ample opportunities for learning and growth.
Flexible work arrangements
We offer the flexibility of remote work, allowing you to balance your personal and professional responsibilities while still contributing to our “We Care” team environment.
Diverse and global client exposure
We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies to support their product development and approval.
Learn from experts
You will work with a team of highly experienced regulatory professionals who can serve as mentors, providing guidance and support as you develop your skills and advance in your career.
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