Job Listing: Manager, Regulatory Affairs

Our Client, a biopharmaceutical company that discovers, develops and commercializes drugs for the treatment of cancer, eye diseases and inflammatory diseases, is looking for a Manager of Regulatory Affairs to join their team on a permanent basis.

On a DAILY BASIS, the Manager of Regulatory Affairs will be responsible for the following:

Management of all regulatory activities associate with our development programs
- Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
- Provide guidance to multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application. Edit or manage the editing of scientific sections of an IND application against the regulatory requirements. Assist with the writing, review and preparation of an IND application. Manage the organization, preparation and review of IND amendments, annual reports and other regulatory documents and correspondence.
- Perform/Manage critical analyses of data (clinical, preclinical and manufacturing protocols and study reports to focus attention on deficient/missing items/explanations.
- Accountable for ensuring the completeness and accuracy and compliance of data provided to all FDA submissions.
- Supervisory responsibility for the planning, preparation and submission of regulatory documentation.

Management of the BLA/CTD planning, preparation and submission process.
- Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA)
- Assist with the scientific writing and review of a BLA and evaluate conformance with the regulatory requirements.

Work closely with clinical sciences, preclinical development, process development, manufacturing, quality assurance/quality control. To achieve company defined goals.

Participate with the defining the requirements, scope, purchase and implementation of a 21 CFR Part 11 compliant electronic document management and regulatory e-submissions system

Continually monitor newly published FDA guidelines and international guidance document sin the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required.

TO BE QUALIFIED for the Manager of Regulatory Affairs, individuals MUST have a degree in a Medical or Science related field and a MINIMUM of 8 years of pharmaceutical industry experience. Research laboratory, process development or manufacturing experience with biotechnology products highly desirable.


All qualified individuals should contact Crysta Lemon at 203-317-2522 or via e-email at clemon@aerotek.com

Required Skills for Manager, Regulatory Affairs Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.