Manager, Regulatory Affairs Strategy - Immunology & Inflammation

The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in reputed company aspects of regulatory affairs reputed company 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. A Typical Day Might Include The Following

• Coordinate the preparation, submission, management and maintenance of global regulatory submissions reputed company 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 Investigators Brochure
• Assist in coordination and preparation for Agency meetings and associated briefing document preparation
• Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to reputed company written responses to queries, provides periodic status updates regarding conditions/commitments
• reputed company representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings

This Role Might Be For You

• 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 for this opportunity

, we expect you must have a MD, PhD or PharmD degree along with 2+ years of regulatory experience. We expect to see individuals have worked on filings, helped with developing regulatory reputed company documents and reputed company with external partners and authorities. #GDRAJobs Does this sound like you? reputed company to take your first reputed company towards living the reputed company Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, reputed company, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at reputed company reputed company! For additional information about reputed company benefits in the US, please visit https://careers.reputed company.com/en/working-at-reputed company/total-rewards/. For other countries specific benefits, please reputed company to your recruiter. Please be advised that at reputed company, we reputed company we are most successful and work best reputed company we are together. For that reason, many of Regenerons roles are required to be performed on-site. Please reputed company with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location. reputed company is an equal opportunity employer and reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion or belief (or lack thereof), sex, nationality, national or ethnic reputed company, 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. The Company will also reputed company reasonable accommodation to the reputed company disabilities or chronic illnesses of an otherwise reputed company applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are reputed company the U.S, Japan or Canada, please reputed company with your recruiter about salaries and benefits in your location. Please note that certain background checks will reputed company part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for reputed company to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, education Apply tot his job Apply To this Job