Regulatory CMC Expert - Biologics

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February 11

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Pharmavise Corporation

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Pharmavise Corporation is the first Continuous Compliance Organization (CCO) dedicated to maintaining the highest standards of quality and regulatory compliance in the life sciences industry. Our esteemed client base includes Fortune 500 companies in pharmaceuticals, medical devices, and biotechnology. We offer bespoke solutions tailored to meet the specific compliance needs of our clients, supporting them from development through commercialization and ensuring they exceed their compliance goals while enhancing patient health and safety.

11 - 50 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• This is a remote position. • From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. • We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. • Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. • We are thrilled to announce an opportunity for an experienced and talented Regulatory CMC Expert in Biologics to join our team. • Below is a detailed job description outlining the responsibilities, qualifications, and expectations for this role:

🎯 Requirements

• Advanced degree (PhD, MS, or equivalent) in a scientific or engineering discipline, preferably in biochemistry, biotechnology, pharmaceutical sciences, or related field. • Minimum of 5 years of experience in regulatory affairs with a focus on CMC for biologic products within the pharmaceutical or biotechnology industry. • Deep understanding of global regulatory requirements and guidelines related to CMC aspects of biologics development, manufacturing, and commercialization. • Experience with preparation and submission of CMC sections of regulatory documents, including INDs, BLAs, and MAAs. • Strong technical background in biopharmaceutical manufacturing processes, analytical methods, and characterization techniques for biologic products. • Excellent communication and interpersonal skills, with the ability to effectively convey complex regulatory concepts and requirements to internal and external stakeholders. • Strong analytical and problem-solving abilities, with the ability to assess regulatory risks and develop strategies for compliance. • Regulatory affairs certification (RAC) or relevant professional certification (e.g., TOPRA Diploma) preferred but not required.