[Remote] CMC Regulatory Affairs Associate (M3 Authoring experience for Biological products )

Note: The job is a remote job and is open to candidates in USA. Parexel is hiring a CMC Regulatory Affairs Associate to author and manage global CMC regulatory submissions for biological products. The role includes preparing submission packages, coordinating submissions and responses to Health Authority requests, and ensuring regulatory compliance across multiple regions.

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

Skills

• 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

Benefits

• Remote work

Company Overview

• PAREXEL is a biopharmaceutical services company that focuses on the development and commercialization of new medical therapies worldwide. It is a sub-organization of EQT. It was founded in 1983, and is headquartered in Raleigh, North Carolina, USA, with a workforce of 10001+ employees. Its website is http://www.parexel.com.

Company H1B Sponsorship

• Parexel has a track record of offering H1B sponsorships, with 38 in 2026, 31 in 2025, 46 in 2024, 41 in 2023, 51 in 2022, 54 in 2021, 33 in 2020. Please note that this does not guarantee sponsorship for this specific role.