Consultant - Biologics

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July 15

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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. • Provide expert consulting services and strategic advice to clients in the biopharmaceutical industry, with a focus on biologics development, manufacturing, and regulatory affairs. • Collaborate closely with clients to understand their needs, challenges, and objectives, and develop tailored solutions to address specific business and regulatory requirements. • Conduct assessments and gap analyses of clients' biologics programs, processes, and operations to identify areas for improvement and optimization. • Develop and implement strategic plans and initiatives to support clients' biologics development and commercialization efforts, including regulatory strategy, CMC (Chemistry, Manufacturing, and Controls) strategy, and lifecycle management. • Provide guidance and support on regulatory submissions for biologic products, including INDs, BLAs, MAAs, variations, and post-approval supplements. • Review and interpret regulatory guidelines, requirements, and industry best practices related to biologics development, manufacturing, and compliance. • Support clients in preparing for regulatory interactions and inspections, including FDA meetings, regulatory agency audits, and responses to regulatory inquiries. • Stay abreast of emerging trends, advancements, and regulatory changes in the biologics industry and provide insights and recommendations to clients.

🎯 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 the biopharmaceutical industry, with a focus on biologics development, manufacturing, or regulatory affairs. • Strong expertise in biologics development and manufacturing processes, including upstream and downstream processing, analytical methods, and characterization techniques. • Deep understanding of global regulatory requirements and guidelines applicable to biologic products, including FDA, EMA, and ICH regulations. • Proven track record of successful consulting engagements or project management in the biopharmaceutical industry, with demonstrated ability to deliver results and drive client satisfaction. • Excellent communication and interpersonal skills, with the ability to effectively engage with clients at all levels of the organization. • Strong analytical and problem-solving abilities, with the ability to assess complex challenges and develop innovative solutions. • Willingness to travel as needed to meet client requirements.

🏖️ Benefits

• Competitive compensation packages are available.