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Mansueto Ventures is home to two of the most iconic and vibrant brands in business publishing: Inc. and Fast Company. Every day, the content, awards, and events produced help entrepreneurs and innovators succeed by providing useful insights, sparking essential conversations, and offering much-needed inspiration.

Inc. is the voice of the American entrepreneur, inspiring and documenting the risk-takers and ultra-driven go-getters who represent the most dynamic force in the American economy.
Fast Company is the world’s leading business media brand, focusing on innovation in technology, leadership, and design to inspire readers to shape the future of business.

","New York, NY","coloredLogo","logoAttachment","thumbnail","thumbnailAttachment","hexCode","#080D0C","headline","Publisher of Inc. and Fast Company, empowering innovators and entrepreneurs.","/companies/mansueto-ventures-careers","hasJobSubmission","isSavedJob","similarJobs",[511,517,525,536,544],{"_429":428,"_434":512,"_452":453,"_444":445,"_243":438,"_441":438,"_427":428,"_111":437,"_431":432,"_433":194,"_454":453,"_442":513,"_425":514,"_455":456,"_430":115,"_476":477,"_460":515,"_478":479,"_480":513,"_482":483,"_484":516,"_486":487},["D",1771459200000],"Atlanta, GA, US, 30383",["B","2619551595"],"/jobs/2619551595-senior-regulatory-affairs-consultant-small-molecules-and-biologics","/jobs?location=Atlanta%2C+GA%2C+US%2C+30383",{"_429":428,"_434":518,"_452":453,"_444":445,"_243":438,"_441":438,"_427":428,"_111":519,"_431":432,"_433":194,"_454":453,"_442":443,"_425":520,"_455":456,"_430":115,"_476":521,"_460":522,"_478":523,"_480":443,"_482":483,"_484":485,"_486":524},["D",1771200000000],"Senior CMC Regulatory Affairs Consultant - Peptides and Oligonucleotides",["B","2619517009"],"3 days ago","/jobs/2619517009-senior-cmc-regulatory-affairs-consultant-peptides-and-oligonucleotides","Senior CMC Regulatory Affairs Consultant - Peptides and Oligonucl...","/jobs?keyword=Senior+CMC+Regulatory+Affairs+Consultant+-+Peptides+and+Oligonucl...",{"_429":428,"_434":526,"_452":453,"_444":527,"_243":528,"_441":529,"_427":428,"_111":437,"_431":194,"_433":194,"_454":453,"_442":530,"_425":531,"_455":532,"_430":115,"_476":521,"_460":533,"_478":479,"_480":530,"_482":534,"_484":535,"_486":487},["D",1771246800000],"Parexel International","Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. In this role, you will help ensure our clients’ investigational, new, and marketed small‑molecule and biologic products are developed and maintained in full alignment with global regulatory requirements. Your primary geographic focus will include the United States, European Union, and Canada, with an emphasis on enabling timely approvals and supporting sustained market access.

You will contribute to both operational execution and strategic regulatory planning, working across a diverse portfolio of programs. The ideal candidate thrives in a collaborative environment and brings a balanced blend of hands‑on authoring expertise and forward‑looking regulatory insight.

Key Responsibilities\nStrategic CMC Leadership

Provide regulatory strategy input for small molecule and biologic products

Support regulatory leads in developing contingency plans for CMC‑related scenarios

Represent CMC Regulatory Affairs in cross‑functional project meetings and provide regulatory guidance in collaboration with global regulatory leads

Submission & Documentation Excellence

Prepare, coordinate, and review CMC and GMP‑related documents for regulatory submissions

Develop CMC strategies for products across all phases—from early development to marketing applications and post‑approval changes

Cross‑Functional Collaboration

Partner with manufacturing, quality, and external organizations to address CMC‑related issues

Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers

Support planning and execution of Health Authority meetings, including mock sessions

Process Optimization & Innovation

Identify and implement process improvements to enhance regulatory efficiency and readiness

Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions

Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer

Regulatory Systems & Reporting

Experience with CPP application filing via eCATS and 510(j)(3) reporting through nextGen portals is a plus

Ensure audit readiness and version control through meticulous documentation and system management

Qualifications\nExperience & Expertise

4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant

Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)

In‑depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules and biologics. Previous experience with combination device products is a plus!

Skills & Attributes

Strategic and proactive mindset with strong operational execution

Excellent analytical, problem‑solving, and negotiation skills

Effective communicator with strong interpersonal, presentation, and leadership abilities

Ability to manage multiple projects independently in a matrixed, multicultural environment

Proficiency in Microsoft Office Suite and regulatory systems

Education

Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field

Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred

RAC certification is a plus

Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based in other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.

EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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