The Sr. Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
In this role, a typical day might include the following:
Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
Assist in coordination and preparation for Agency meetings and associated briefing document preparation
Manages and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
Perform research to support the development of regulatory strategy for the assigned clinical development program
Maintains knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed
Exercise discretion and independent judgment in the performance of the duties described above
This role might be for you if:
4+ years of pharmaceutical industry experience in regulatory affairs; preferred
Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
High attention to detail; ability to organize and prioritize assigned projects according to corporate goals
Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization
Proficient in written, oral, and interpersonal communications in English
Ph.D or PharmD required
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.