Requirements:
Must be local to Boston area to accommodate flexible hybrid schedule
Responsibilities:
Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary teams (e.g. CMC Teams, Program Teams) and with business partners such as CDMOs, consultants, etc.
Collaborate with cross-functional teams to generate and refine the product development strategy.
Lead preparation of high-quality global clinical trial applications in the US, EU and ROW including the preparation of CMC content of initial INDs/CTAs and amendments, GMO applications, responses to agency questions, and maintenance activities.
Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams and timelines relevant to assigned projects or programs.
Actively contribute to the preparation and execution of global agency meetings.
Work closely and creatively with technical teams to support the implementation of manufacturing and analytical development strategies.
Identify and clearly communicate regulatory CMC risks and opportunities to both the technical team and Regulatory teams. Develop and implement global regulatory CMC strategies that maximize probability of success.
Support the development and refinement of internal regulatory processes and standards.
Actively monitor regulatory policy and intelligence and disseminate information to inform program strategy.
Monitor the development of new requirements, guidelines and trends through information gathering and participation in industry groups.
Additional Skills & Qualifications:
Bachelor’s degree in a scientific discipline; Masters, PharmD, or PhD preferred.
Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, DSURs and Agency briefing documents in US and ex-US.
Experience in gene therapy, cell therapy or nucleic acid based therapeutic programs a plus, although not required.
Strong knowledge of current Good Manufacturing Practices (GMP), US and EU drug and biologic regulations and guidelines including ICH, FDA and EMA guidelines.
Ability to effectively organize and prioritize tasks to achieve established deadlines.
Ability to work both independently and within project teams, committees, etc. to achieve group goals.
Excellent verbal and written communication skills.
Excellent organizational and program management skills that ensure timely completion of objectives by appropriate prioritization, scheduling and assignment of tasks.
Strong collaborator with multi-disciplinary teams.
Creative problem solving and strategizing abilities.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
