The Director of Regulatory Affairs will provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for Regeneron’s clinical asset candidates.
In this role, a typical day might include the following:
- This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development of all aspects of Regeneron’s quality, preclinical and clinical drug development programs, policies and procedures, so that Development teams can meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements.
- Develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management and by analysis of guidance’s and assessment of drug developed for similar indication to obtain approval of activities in support of Regeneron’s development and marketing objectives within specified timelines
- Liaison responsible for communication with FDA and other health authorities for assigned programs
- Manage/lead regulatory activities associated with Regeneron assigned drug development programs.
- Management of the planning, preparation and submission of licensing applications (BLA).
- 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.
- Manage and mentor direct reports and/or junior staff members.
This role might be for you if:
- If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
- If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
- If you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals
- You bring strong interpersonal skills both written and verbally
To be considered, you must possess excellent written and verbal communication skills along with a MD, Ph.D. or Pharm D. degree. We expect a minimum of 10 years of pharmaceutical industry experience, at least 5 of which should include regulatory experience.
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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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$182,800.00 - $304,600.00