Key Duties & Accountabilities:\t

•\tActively 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.

•\tCollaborate with cross-functional teams to generate and refine the product development strategy.

•\tLead 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.

•\tCoordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams and timelines relevant to assigned projects or programs.

•\tActively contribute to the preparation and execution of global agency meetings.

•\tWork closely and creatively with technical teams to support the implementation of manufacturing and analytical development strategies.

•\tIdentify 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.

•\tSupport the development and refinement of internal regulatory processes and standards.

•\tActively monitor regulatory policy and intelligence and disseminate information to inform program strategy. 

•\tMonitor the development of new requirements, guidelines and trends through information gathering and participation in industry groups.

Qualifications:

•\tBachelor’s degree in a scientific discipline; Masters, PharmD, or PhD preferred. 

•\tMinimum 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.

•\tExperience in gene therapy, cell therapy or nucleic acid based therapeutic programs a plus, although not required.

•\tStrong knowledge of current Good Manufacturing Practices (GMP), US and EU drug and biologic regulations and guidelines including ICH, FDA and EMA guidelines.

•\tAbility to effectively organize and prioritize tasks to achieve established deadlines.

•\tAbility to work both independently and within project teams, committees, etc. to achieve group goals.

•\tExcellent verbal and written communication skills.

•\tExcellent organizational and program management skills that ensure timely completion of objectives by appropriate prioritization, scheduling and assignment of tasks.

•\tStrong collaborator with multi-disciplinary teams.

•\tCreative 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 for other accommodation options.