Regulatory CMC Expert in Biologics

Pharmavise Corporation; United States; A distancia; USD 130.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation

SME network

EEO employer commitment

Descripción de la vacante

PharmaviseConsulting Corp. is seeking an experienced Regulatory CMC Expert in Biologics for a remote position in the United States.

You will lead CMC regulatory strategy, prepare submissions, and collaborate with cross-functional teams to ensure compliance across INDs, BLAs, and MAAs. The role requires a PhD/MS in a scientific field with 5+ years in regulatory affairs for biologics, plus deep knowledge of FDA/EMA/ICH guidelines.

Formación

• Advanced degree (PhD, MS, or equivalent) in a scientific or engineering discipline; preferably 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 convey complex regulatory concepts to internal and external stakeholders.
• Strong analytical and problem-solving abilities, with the ability to assess regulatory risks and develop compliance strategies.
• Regulatory affairs certification (RAC) or TOPRA Diploma preferred but not required.

Responsabilidades

• Lead and provide expert guidance on CMC regulatory strategy and submissions for biologics.
• Interpret and apply global regulatory requirements (ICH, FDA, EMA) for biologics CMC aspects.
• Collaborate with cross-functional teams to develop CMC regulatory strategies aligned with development objectives.
• Prepare, review, and contribute to regulatory submissions (INDs, BLAs, MAAs).
• Provide regulatory assessment of CMC changes, deviations, investigations, and manufacturing investigations.
• Support interactions with regulatory agencies, including briefing documents and agency meetings.
• Stay abreast of emerging regulatory trends and provide insights to internal stakeholders.
• Serve as SME on CMC regulatory requirements and train internal teams.

Conocimientos

Regulatory expertise

CMC for biologics

Global regulatory experience

Communication skills

Analytical problem solving

Educación

PhD in Biochemistry/Biotechnology/Pharmaceutical sciences

Descripción del empleo

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. Visit us atwww.pharmavise.com

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:

Responsibilities

• Lead and provide expert guidance on Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and submissions for biologic products, including monoclonal antibodies, recombinant proteins, vaccines, and cell therapies.
• Interpret and apply global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) related to CMC aspects of biologics development, manufacturing, and commercialization.
• Collaborate with cross-functional teams, including manufacturing, process development, quality assurance, and regulatory affairs, to develop and execute CMC regulatory strategies aligned with product development objectives.
• Prepare, review, and contribute to regulatory submissions for biologic products, including INDs, BLAs, MAAs, variations, and post-approval supplements.
• Provide regulatory assessment of CMC changes, deviations, investigations, and manufacturing investigations, ensuring compliance with regulatory requirements and guidelines.
• Support interactions with regulatory agencies, including preparation of briefing documents, responses to regulatory inquiries, and participation in agency meetings.
• Stay abreast of emerging regulatory trends, changes, and updates in the biologics industry and provide insights and recommendations to internal stakeholders.
• Serve as a subject matter expert on CMC regulatory requirements for biologic products, providing training and guidance to internal teams as needed.

Qualifications

• 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.

Competitive compensation packages are available.

Be part of our network of Subject Matter Experts.

EEO Employer: PharmaviseConsulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.PharmaviseConsulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please . PharmaviseConsulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients.

When you joinPharmavise, you become part of a team that values Excellence Through Quality.