Actalent
Location
Rockville, MD | United States
Job description
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
6-10+ 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
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 [email protected] (%[email protected]) for other accommodation options.
Job tags
Salary