Pharmavise Corporation ยท 1 month ago
Consultant/Biologics (Individual Contributor Role)
United States
Contract
Hybrid
Senior Level
5+ years expPharmavise Corporation is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. They are seeking a Consultant/Biologics to provide expert consulting services and strategic advice to clients in the biopharmaceutical industry, focusing on biologics development, manufacturing, and regulatory affairs.
Food and BeverageHealth Care
Responsibilities
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
Qualification
Required
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
Company
Pharmavise Corporation
โฆ๐๐ฑ๐๐๐ฅ๐ฅ๐๐ง๐๐ ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒโฆ: ๐๐ก๐๐ซ๐ฆ๐๐ฏ๐ข๐ฌ๐, ๐ฒ๐จ๐ฎ๐ซ ๐ฌ๐ญ๐ซ๐๐ญ๐๐ ๐ข๐ ๐๐ข๐๐ ๐๐๐ข๐๐ง๐๐๐ฌ, ๐๐๐๐ฅ๐ญ๐ก๐๐๐ซ๐ ๐๐ง๐ ๐๐จ๐ฏ๐๐ซ๐ง๐ฆ๐๐ง๐ญ ๐ฌ๐จ๐ฅ๐ฎ๐ญ๐ข๐จ๐ง๐ฌ ๐ฉ๐๐ซ๐ญ๐ง๐๐ซ.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2020-04-04Seed
Leadership Team
Ricardo Joseph
Founder and CEO
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