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Senior Manager, Regulatory Affairs Strategy
4 weeks ago
Senior Manager, Regulatory AffairsThe Senior 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 BrochureAssist in coordination and preparation for Agency meetings and associated briefing document preparationManages 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/commitmentsProvide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetingsPerform research to support the development of regulatory strategy for the assigned clinical development programMaintains knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as neededExercise discretion and independent judgment in the performance of the duties described aboveThis 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 preferredIf you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goalsYou bring strong interpersonal skills both written and verballyTo be considered for this opportunity, you must possess excellent written and verbal communication skills along with a MD, Ph.D. or Pharm D. degree. We expect a minimum of 5 years of pharmaceutical industry experience, at least 3 of which should include regulatory experience.
