You need to have the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development. You will interact with all aspects of Regeneron’s quality, preclinical, and clinical drug development programs, policies, and procedures. This is vital so the development teams are able to meet all objectives within agreed timelines ensuring compliance is maintained with all regulatory commitments/requirements.
In this role, a typical day might include the following:
Act as liaison between company and FDA and other health authorities for assigned programs
Develop regulatory strategies for assigned programs, in order to support Regeneron’s development and marketing objectives. This will be achieved through analysis of guidances and assessment of other drugs, and in collaboration with Regeneron’s senior regulatory management.
Management of activities associated with Regeneron development programs.
We expect that you will participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
Provide mentorship to multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application or CTA for ex-US studies. Edit or lead the editing of scientific sections of regulatory documentation 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/lead critical analyses of data (clinical, preclinical and manufacturing), independently developing interpretations and conclusions.
Perform reviews of clinical protocols and study reports to focus attention on deficient/missing items/explanations.
Accountable for ensuring the completeness and accuracy of all regulatory submissions.
Supervisory responsibility for the planning, preparation and submission of regulatory documentation.
Management of the planning, preparation and submission process for licensing applications.
Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA) or MAA and the subsequent regulatory review process.
Assist with the scientific writing and review of a BLA and evaluate conformance with the regulatory requirements.
Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required.
This role might be for you if:
- We require an MD, Ph.D or PharmD
- Expert knowledge of regional health authority regulations and advanced knowledge of global regulations
- Demonstrated interactions with local health authorities
- Excellent communication skills and strong analytical skills
- Demonstrated leadership and project management skills, including cross-functional communication
- We desire at least 5+ years of RA experience.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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