Position Summary: The Director of Regulatory Affairs will spearhead the creation and execution of a unified regulatory strategy, encompassing regulatory operations, to ensure and sustain market access for assigned products throughout all development stages. This role involves building and nurturing strong relationships with regulatory bodies, particularly the FDA. The Director will lead a team of regulatory professionals, providing guidance on regulatory requirements for various dosage forms and delivery systems, and recommending suitable actions. Responsibilities: + Global Strategy Development : Craft and implement global regulatory strategies for assigned projects, working closely with Regional Regulatory Affairs and Regulatory CMC teams. + Regulatory Representation : Serve as the company's primary representative on regulatory issues with the FDA and other health authorities, covering all products and business areas. + Leadership and Team Development : Lead global and regional regulatory teams on assigned projects. Provide leadership to the Regulatory department, including training, developing current team members, and recruiting new talent. + US Regulatory Strategy : Develop and execute US-specific regulatory strategies and contingencies for assigned projects. + Primary FDA Liaison : Act as the main point of contact for the FDA on assigned projects. + SOP Management : Oversee the review and approval of Standard Operating Procedures (SOPs) related to regulatory submissions and reporting. Implement new processes and policies to improve company efficiency. + Strategic Communication : Communicate regulatory strategies and plans to management, cross-functional teams, and partners/collaborators to ensure alignment. + Competitive Strategy Development : Contribute to the creation of competitive regulatory strategies that expedite development, maximize success probabilities, and mitigate risks. + Submission Leadership : Lead the preparation of regulatory submissions, including INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications. Coordinate with functional groups to define contributions and lead regulatory submission teams. + Agency Meeting Preparation : Prepare company teams for meetings with the FDA and other health agencies as needed. + CRO Coordination : Serve as the primary interface with Regulatory CROs for submission coordination and preparation. + Regulatory Knowledge Maintenance : Stay updated on the global regulatory landscape, including regulations, guidance, and competitive environment. Additional Skills & Qualifications: + Educational Background : Bachelor’s degree in a scientific discipline is required; an advanced scientific degree is preferred. + Certifications : Regulatory Affairs Certification is highly desirable. + Experience : + Minimum of 10 years of experience in the pharmaceutical industry, with at least 7 years in Regulatory Affairs leadership roles. + Global experience is preferred. + Experience across multiple phases of development in various therapeutic areas. + Proven track record in preparing FDA submissions. + Knowledge : + In-depth understanding of the drug development process and global submission procedures. + Familiarity with global regulatory guidelines and their application to overall regulatory strategy. + Skills : + Strong inter-dependent partnering skills, team-oriented mindset, and the ability to influence outcomes. + Excellent organizational, communication, and time management skills to handle multiple ongoing projects simultaneously. + Ability to innovate, analyze, and solve problems with minimal supervision and a keen attention to detail. 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.