Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
4 Year Degree
SciLucent, LLC, a Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, is looking to expand its regulatory affairs consultant team with an experienced scientific and regulatory affairs professional with strong interpersonal skills. We are looking for an enthusiastic, adaptable, self-motivated individual with excellent communication skills and demonstrated project management ability for this position.
The responsibilities of the position include:
Providing strategic support and guidance to clients to ensure that developmental activities are effective, and that regulatory documentation is accurate and compliant with relevant regulations, guidelines, and industry standards;
Compiling, organizing, and managing the production of clear and persuasive regulatory submissions for pharmaceuticals, biologics, and combination products;
Drafting and reviewing all regulatory documents for scientific content, quality, and messaging;
Developing and managing the implementation of scientific/regulatory strategies and associated project timelines;
Leading and guiding cross-functional project team professionals
The ideal candidate will have the following:
At least a Bachelor’s degree in a relevant scientific discipline (e.g., biology, chemistry, biochemistry, biomedical engineering, etc.);
A minimum of 3 years’ experience as a scientific/regulatory professional and a demonstrated understanding and familiarity with pharmaceutical and biological development and registration;
Demonstrated ability to write and review scientific and regulatory documents;
Strong knowledge of US industry standards and applicable guidance documents;
Strong project management, communication, and interpersonal skills;
Ability to build and maintain client relationships.
Telecommuting is allowed.
Additional Salary Information: We offer a collegial work environment, the opportunity to work with knowledgeable consultants, a competitive salary, flexible benefits, retirement plan, generous paid time off plan, profit sharing, and a tremendous opportunity for growth. This position may require occasional travel.
Internal Number: RA 2019
About SciLucent LLC
SciLucent, LLC is a Northern Virginia-based scientific and regulatory consulting firm providing services to manufacturers, distributors, and marketers of healthcare products. We offer a congenial work environment, the opportunity to work with knowledgeable regulatory consultants, a competitive salary, flexible benefits, profit sharing, and a tremendous opportunity for growth.