Description:

Our client is currently seeking a Director level candidate to join their team.

Job requirements:

The candidate will be a self-starter and provide regulatory oversight for assigned products, in order to optimize and obtain shortest time to approval by regulatory agencies

• Independently manages projects, functioning as the single, accountable, global point of contact on those projects
• Independently interacts with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our Company’s investigational and marketed drugs/biologics
• Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions
• Responsible for regulatory review and approval for all submissions and associated documentation
• Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously
• Provide expert advice to internal teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
• Represents our Company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our Company’s teams for meetings with FDA at any phase of drug development
• Cross-functional efforts to prepare for advisory committees
• Coordinate interactions with foreign agencies through Regulatory Affairs Europe (RAE) and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously
• Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials
• Participate in regulatory due diligence activities for licensing candidate review

Additional Skills & Qualifications:

• Bachelors Degree is a must
• 10 years experience in regulatory settings
• Regulatory strategy experience
• EU and US FDA strategy and engagement
• Experience in Oncology is highly preferred
• Great communicator and ability to have good written skills
• A native English speaker would be ideal
• Writing documentation to regulatory authorities

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.