Full-time
CMC Regulatory Affairs Associate (M3 Authoring experience for Biological products )
Competitive
Mid, Senior LevelScience & PharmaceuticalPosted 21d ago
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Role overview
Job type
Salary
Competitive
Location
Sector
Posted
21 days ago
Job description
CMC Regulatory Affairs Associate (M3 Authoring experience for Biological products )
Tags
63
FAIR MATCH
Experience Level
100
Skill
49
Industry Exp.
68
Clinical Trials
Pharmaceutical
Biotechnology
Consulting
Responsibilities
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
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)
Coordinate all assigned activities
Ensure compliance to all client SOPs/training sessions
Preferred
a degree in Regulatory Affairs is advantageous
Vaccines preferable
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
Remote work
Glassdoor
3.8
Global clinical research and biopharmaceutical services company.
Raleigh, North Carolina, USA
http://www.parexel.com
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Legal and Compliance
Engineering and Development
Management and Executive
Accounting and Finance
Customer Service and Support
Education and Training
Sales
Marketing
Human Resources
Trends of Total Sponsorships
*2026
(38)
2025
(31)
2024
(46)
2023
(41)
2022
(51)
2021
(54)
Qualifications
Excellent communication and stakeholder management skills
Strong organizational and time management skills
Strong problem-solving skills
Strong oral skills, with proven ability to work efficiently as part of a team
Strong interpersonal skills
University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD)
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
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)
A degree in Regulatory Affairs is advantageous
Vaccines preferable
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
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
Required skills
M3 Authoring, CMC Regulatory Affairs, Biological Products, Veeva, Manufacturing Practice, Regulatory CMC Writing, Regulatory Frameworks, Stakeholder Management
Preferred skills
a degree in Regulatory Affairs is advantageous, Vaccines preferable, Experience using Veeva
Experience
2+ years
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