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 cultivating and maintaining 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 appropriate actions.

Responsibilities:

Develop and implement global regulatory strategies for assigned projects, in collaboration with Regional Regulatory Affairs representatives and Regulatory CMC.
Represent company in all regulatory matters with the FDA and other health authorities for all products and business areas.
Lead global and/or regional regulatory teams on assigned projects.
Provide leadership to the Regulatory department, including training, developing the current team, and selecting and hiring new members.
Develop and execute US regulatory strategies and contingencies for assigned projects.
Act as the primary liaison with the FDA for assigned projects.
Oversee the review and approval of Standard Operating Procedures (SOPs) related to the preparation, submission, and reporting of information to regulatory authorities. Plan and implement new processes and policies to enhance company efficiency.
Communicate regulatory strategies and plans to management, cross-functional teams, and partners/collaborators to ensure alignment.
Contribute to the development of competitive regulatory strategies that expedite development, maximize success probabilities, and mitigate risks.
Lead the preparation of submissions, including INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications. Coordinate with functional groups to define contributions to submissions and lead regulatory submission teams for assigned projects.
Prepare the company team for FDA and other health agency meetings as needed.
Serve as the primary contact with Regulatory CROs for coordinating and preparing submissions.
Stay informed about the global competitive landscape, regulatory environment, regulations, and guidance.

Additional Skills & Qualifications:

Bachelor’s degree in a scientific discipline; an advanced scientific degree is preferred.
Regulatory Affairs Certification is highly desirable.
Over 10 years of experience in the pharmaceutical industry, including more than 7 years in Regulatory Affairs leadership roles
Global experience is preferred.
Experience across multiple phases of development in various therapeutic areas.
Proven experience in preparing FDA submissions.
In-depth knowledge of the drug development and global submission processes.
Familiarity with global regulatory guidance as it pertains to overall regulatory strategy.
Strong inter-dependent partnering skills, team orientation, and the ability to influence outcomes.
Excellent organizational, communication, and time management skills to manage 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 for other accommodation options.

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