Biologics, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
Strategic need for a Consultant, Regulatory CMC (Biologics) for a well-established and rapidly growing and global Biotechnology organization. The Consultant, Regulatory CMC (Biologics), Biotechnology will be responsible for partnering with internal staff to drive global Regulatory CMC submissions forward. Ideally this consultant will have some exposure to Biologics and prior experience in growing Emerging Markets. This is a hands-on role that will require an ability to execute on the CMC strategy and groundwork in place while also focusing the growth strategy and direction in key Emerging Markets. Our Client is at the cutting edge of providing lifesaving therapies. They have products in the commercial market and are working towards additional innovative therapies.
Qualifications: • 7-10+ years of experience in global Regulatory CMC submissions preferably at the Senior Manager or Associate Director+ level • 1-2+ years in Biologics is preferred • Experience working cross functionally across Quality, Process Development, Tech Transfer and working with International leads on the ground in Emerging Markets • Experience with Biological products is preferred • Experience with Phase 1-3 programs with Orphan/Breakthrough therapy designations
Job Duties: • Ensures completion of high-quality submissions, adhering to regulatory guidelines, regional specifications, and company standards • Monitor and analyze appropriate regulatory agency activities in areas of interest to the company and assess impact on specific projects • Assess compliance of CMC document with the current Guidelines and Regulations • Assess regulatory impact of proposed CMC changes to licenses or clinical trial applications • Responsible for coordinating all aspects of regulatory CMC submissions relevant to assigned projects or programs • Identify and assess regulatory risks associated with product development for assigned programs and assist in defining strategies to mitigate risks • Guide the organization and preparation of clear and effective submissions. Education: • Bachelor’s Degree required. Life or Health Sciences preferred.
Term and Start: • 6-12+ month consulting opportunity • Onsite in Waltham, MA • Ability to start early December 2018/January 2019
Internal Number: 1
About GForce Life Sciences
GForce Life Sciences connects highly coveted consultants to the needs of life sciences leaders. Regulatory pressures, altering market demands and healthcare refinement are changing the landscape of the global life sciences industry. Patients, providers, payers, and regulators are seeking a higher quality of care and better therapeutic benefits, along with reduced costs and enhanced transparency.
With a 98% success rate, GForce Life Sciences has worked with some of the world’s leading pharmaceutical and medical device companies to address these challenges by providing consultants to assist our clients in delivering on the promises they have made to their clients (internal and external). GForce recognizes that there is no “one-size-fits-all” approach to achieving growth and battling industry-wide challenges, therefore we begin with your specific needs and work from there to identify the consultant or team that is the best fit.
Unlike larger, “factory firms,” our boutique approach allows us to hand-pick and closely monitor the best consultants for your company and projects. Finally, we back our services with the industry’s leading technology infrastructure, assuring agile, transparent, personalized consulting solutions and business reporting intelligence.