Job Information
Actalent Biologic Operator I in Branchburg, New Jersey
Job Summary
Under the general guidance of the Director Regulatory Affairs, Regulatory Affairs Associate plays a crucial role in ensuring the quality, and accuracy of drug product submissions to regulatory authorities. Some of the key functions include ensures the smooth compliant flow of information between all functional areas, external partners and regulatory authorities for timely reporting to the FDA.
Essential Responsibilities
Contribution to submission strategy and timing
Track and execute submission plans, effectively managing submission deadlines across product portfolio, coordinating activities between relevant functions
Preparation of submission ready components from internal contributors according to regional regulatory guidance and internal standards
Creation of regulatory dossiers according to agency requirements, eCTD Guidance & Specifications and agreed upon timelines
Execute the submission of regulatory applications (Marketing Authorizations, Investigational Application, Orphan Drug Designations, Scientific Advice, etc.) through the appropriate systems (CESP, lRIS, CTIS, NextGen, CDER Direct, etc.)
Participation in information system and software update projects as well as ongoing system validations
Qualifications
Around 3 years of prior relevant experience within a pharmaceutical company.
Experience with MS Word (e.g., Authoring templates), Adobe Acrobat, electronic publishing software, document management systems and database management.
Demonstrate ability to work independently as well as within teams
Demonstrated experience in compiling, validating, and submitting in eCTD (e.g., Marketing Authorization Applications) preferred.
Position Type and Expected Hours of Work
This is a Part-time remote position, with operations occurring between the hours of 9am-5pm. (29 hours weekly)
Working hours may vary anywhere from several hours before opening to several hours after closing.
Additionally, weekend hours may be needed depending upon workload demands.
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.