The Senior Director, Regulatory Affairs works closely with cross-functional teams to develop and implement regulatory strategy for medicines in development and to prepare and submit a variety of applications such as INDs, CTAs, NDAs, and MAAs to US and International Regulatory Authorities. Work with the commercial/legal team to review and submit marketing and promotional materials. Responsibilities will include actively leading the development and implementation of regulatory strategy including identifying regulatory risks and pathways for expedited development. Serve as the regulatory representative or supervisor on project teams, active involvement in writing and review of regulatory submissions. Interfacing directly with health authorities with the ability to problem solve via established relationships with FDA personnel. The incumbent will have demonstrated leadership capabilities and will proactively keep key personnel within the Company updated on changes in the global regulatory environment.
Essential Duties and Responsibilities:
+ Implement regulatory strategies for development programs and products
+ Track & prepare all submissions to regulatory agencies, including IND/CTA and NDA/MAA submissions (Annual Reports, Meeting Requests, Briefing Documents, and other submissions).
+ Liaise with the FDA and EMA as appropriate.
+ Develop and maintain regulatory timelines for development programs and submissions
+ Provide regulatory input to cross-functional project teams..
+ Provide project-specific regulatory support to resolve issues.
+ Review Federal Register notices and prepare Regulatory Alerts regarding FDA/European Union regulations
+ Assist with the development of standard operating procedures (SOP)
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Required Education and Experience:
+ 8 years previous experience in RA.
+ B.S. or B.A. in a pharmaceutical of science field
+ Demonstrated leadership experience in Regulatory Affairs is required
Required Knowledge, Skills, Abilities & Behaviors:
+ Strong understanding of the FDA and EMA regulations and drug development process
+ Strong understanding of the intra-dynamics of the FDA with established FDA relationships.
+ Demonstrated ability to work both independently and as a part of a multidisciplinary team to author, assemble and coordinate review by departments and contractors to complete high quality regulatory submissions on time.
+ Strong verbal and written communication skills
+ Detail oriented with good organizational skills
+ Excellent written and verbal communication skills to collaborate well internally and externally
+ This job operated in a professional office environment.
+ This role routinely uses standard office equipment such as computers, phones and photocopiers.
+ This position is required to work occasional nights and weekends to meet company demands.
Street: 640 Lee Road