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Every career with Hearst Television is like a story. How it develops, where it takes you, the milestones you reach along the way – you’ve got a lot to look forward to as your unique career story unfolds. Hearst Television, a subsidiary of Hearst, owns and operates local television and radio stations serving nearly three dozen U.S. cities, reaching 24 million U.S. television households. Through its partnership with nearly all major networks, Hearst Television distributes national content across more than 120 video channels, including programming from ABC, NBC, CBS, CW, MY Net, MeTV, This TV, Estrella, and more. Hearst Television is recognized as one of the industry's premier companies. It has been honored with numerous awards for distinguished journalism and industry innovation, including the Walter Cronkite Award for political journalism, the national Edward R. Murrow Award, the DuPont-Columbia Award, and the George Foster Peabody Award.

","New York, NY","coloredLogo","logoAttachment","Hearst.png","thumbnail","thumbnailAttachment","Hearst_TV_Careers.png","hexCode","#2D75B9","headline","National multimedia company reaching 24 million households","https://production-rails-default.s3.amazonaws.com/uploads/company/logo_attachment/1072/Hearst.png","/companies/hearst-television","https://production-rails-default.s3.amazonaws.com/uploads/company/thumbnail_attachment/1072/Hearst_TV_Careers.png","hasJobSubmission","isSavedJob","similarJobs",[513,519,531,539,549],{"_429":428,"_434":514,"_452":453,"_444":445,"_243":438,"_441":438,"_427":428,"_111":437,"_431":432,"_433":194,"_454":453,"_442":515,"_425":516,"_455":456,"_430":115,"_476":477,"_460":517,"_478":479,"_480":515,"_482":483,"_484":518,"_486":487},["D",1771459200000],"Phoenix, AZ, US, 85003",["B","2619518577"],"/jobs/2619518577-senior-regulatory-affairs-consultant-small-molecules-and-biologics","/jobs?location=Phoenix%2C+AZ%2C+US%2C+85003",{"_429":428,"_434":520,"_452":453,"_444":521,"_243":522,"_441":523,"_427":428,"_111":437,"_431":194,"_433":194,"_454":453,"_442":524,"_425":525,"_455":526,"_430":115,"_476":527,"_460":528,"_478":479,"_480":524,"_482":529,"_484":530,"_486":487},["D",1771426800000],"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.

#J-18808-Ljbffr\n","Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Se...","Atlanta, Georgia, United States, 30383",["B","2621512643"],"Work at Parexel International","1 days ago","/jobs/2621512643-senior-regulatory-affairs-consultant-small-molecules-and-biologics","/jobs?keyword=Parexel+International","/jobs?location=Atlanta%2C+Georgia%2C+United+States%2C+30383",{"_429":428,"_434":532,"_452":453,"_444":445,"_243":438,"_441":438,"_427":428,"_111":533,"_431":432,"_433":194,"_454":453,"_442":443,"_425":534,"_455":456,"_430":115,"_476":535,"_460":536,"_478":537,"_480":443,"_482":483,"_484":485,"_486":538},["D",1771113600000],"CMC Regulatory Affairs Consultant with experience in peptides and oligonucleotid",["B","2619532733"],"4 days ago","/jobs/2619532733-cmc-regulatory-affairs-consultant-with-experience-in-peptides-and-oligonucleotid","CMC Regulatory Affairs Consultant with experience in peptides and...","/jobs?keyword=CMC+Regulatory+Affairs+Consultant+with+experience+in+peptides+and...",{"_429":428,"_434":540,"_452":453,"_444":521,"_243":541,"_441":542,"_427":428,"_111":543,"_431":194,"_433":194,"_454":453,"_442":544,"_425":545,"_455":526,"_430":115,"_476":527,"_460":546,"_478":543,"_480":544,"_482":529,"_484":547,"_486":548},["D",1771426800000],"A leading global regulatory affairs firm is seeking a CMC Regulatory Affairs Senior/Consultant in Bismarck, North Dakota, to ensure compliance with global regulatory requirements for small molecules and biologics. The ideal candidate will have 4–6 years of regulatory experience, strong strategic skills, and collaboration abilities. Responsibilities include providing regulatory strategy input and preparing submission documents. Candidates from the Eastern Time Zone are preferred, but exceptional candidates from other areas will also be considered.\n#J-18808-Ljbffr\n","A leading global regulatory affairs firm is seeking a CMC Regulatory Affairs Senior/Consultant in Bismarck, North Dakota, to ensure compliance with...","Global CMC Regulatory Consultant (Senior)","Bismarck, North Dakota, us, 58502",["B","2621510112"],"/jobs/2621510112-global-cmc-regulatory-consultant-senior","/jobs?location=Bismarck%2C+North+Dakota%2C+us%2C+58502","/jobs?keyword=Global+CMC+Regulatory+Consultant+%28Senior%29",{"_429":428,"_434":550,"_452":453,"_444":521,"_243":551,"_441":552,"_427":428,"_111":543,"_431":194,"_433":194,"_454":453,"_442":553,"_425":554,"_455":526,"_430":115,"_476":555,"_460":556,"_478":543,"_480":553,"_482":529,"_484":557,"_486":548},["D",1771246800000],"A global regulatory consultancy in Baton Rouge seeks an experienced CMC Regulatory Affairs Senior/Consultant. The role includes developing regulatory strategies for small molecules and biologics to ensure compliance with FDA and EMA standards. Ideal candidates bring 4-7 years of relevant experience and possess strong analytical and communication skills. This position promotes collaboration across diverse teams to ensure successful regulatory submissions and market access.\n#J-18808-Ljbffr\n","A global regulatory consultancy in Baton Rouge seeks an experienced CMC Regulatory Affairs Senior/Consultant. The role includes developing regulato...","Baton Rouge, Louisiana, us, 70873",["B","2594892671"],"3 days ago","/jobs/2594892671-global-cmc-regulatory-consultant-senior","/jobs?location=Baton+Rouge%2C+Louisiana%2C+us%2C+70873","actionData","errors"]