Job summary
Job post source
This job is directly from Parexel
Job overview
The Senior Regulatory Affairs Associate, CMC Biologics role at Parexel involves shaping and executing global CMC regulatory strategies to support early-stage and marketed biologic products, impacting life-saving therapies.
Responsibilities and impact
The role includes developing global CMC regulatory strategies, authoring and managing regulatory submissions, leading cross-functional meetings, assessing manufacturing changes, providing regulatory guidance, and collaborating with R&D, manufacturing, and quality teams to ensure compliance and support product lifecycle management.
Experience and skills
Candidates need a bachelor's degree in a scientific field (advanced degree preferred), 4+ years in CMC Regulatory Affairs in pharma or biotech, experience with regulatory submissions, strong knowledge of global regulatory guidelines, excellent communication and project management skills, ability to work EST hours, and willingness to travel 15-20%. Previous CMC biologics experience is required.
Career development
The position offers opportunities for professional growth and development within a collaborative team of regulatory professionals.
Work environment and culture
Parexel promotes a mission-driven, innovative, and patient-focused culture with a collaborative and experienced regulatory team environment.
Company information
Parexel is a global biopharma services company supporting drug development and regulatory strategies for life-saving therapies.
Team overview
The candidate will join a large, dedicated Functional Service Provider program supporting a global biopharma leader, working closely with cross-functional teams.
Job location and travel
The position is open to candidates in the US or Canada, preferably in EST time zones, with some travel required (15-20%).
Unique job features
The role offers a unique opportunity to work on both early-stage and approved biologic programs within a global regulatory framework, emphasizing strategic impact and cross-functional leadership.
Company overview
Parexel is a global biopharmaceutical services organization that provides comprehensive drug development and regulatory consulting services to the pharmaceutical, biotechnology, and medical device industries. They make money by offering clinical research, regulatory consulting, and market access services that help clients expedite the development and approval of new therapies. Founded in 1982, Parexel has a long history of innovation in clinical research and has been involved in the development of many significant medical treatments.
How to land this job
Position your resume to highlight your expertise in CMC biologics regulatory affairs, emphasizing your experience with global regulatory strategies and submissions like INDs and IMPDs.
Focus on showcasing your ability to lead cross-functional teams, manage complex regulatory projects, and provide strategic guidance on manufacturing and process changes.
Apply through multiple platforms including Parexel’s corporate careers site, LinkedIn, and other biotech job boards to maximize your application visibility.
Connect on LinkedIn with professionals in Parexel’s regulatory affairs or biologics divisions; use ice breakers like commenting on recent Parexel regulatory achievements or asking about their experience working in the FSP program.
Optimize your resume for ATS by incorporating keywords from the job description such as 'CMC regulatory strategy,' 'global submissions,' 'IND,' 'IMPD,' 'cross-functional leadership,' and 'biologics manufacturing compliance.'
Leverage Jennie Johnson’s Power Apply feature to automate tailored applications, identify optimal job portals, and discover LinkedIn contacts for networking, saving you valuable time and increasing your chances at Parexel.
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