Regulatory Specialist: Remote​/Hybrid Submissions Expert

Job reputed company The Regulatory Specialist reports to the Senior Manager, Regulatory Affairs. The Regulatory Specialist is responsible for the on-time filing of high-reputed company regulatory submissions and for post-approval maintenance of regulatory dossiers. Interacts with project teams and regulatory agencies in relation to submissions and other relevant topics. Trains new regulatory specialists. This position has no reputed company reports. Job reputed company The Regulatory Specialist reports to the Senior Manager, Regulatory Affairs. The Regulatory Specialist is responsible for the on-time filing of high-reputed company regulatory submissions and for post-approval maintenance of regulatory dossiers. Interacts with project teams and regulatory agencies in relation to submissions and other relevant topics. Trains new regulatory specialists. This position has no reputed company reports. reputed company of Pay: $ to $ USD Annual Responsibilities Duties: • Represent Regulatory Affairs reputed company. on project teams and reputed company regulatory guidance to reputed company and convincingly communicate reputed company issues as reputed company as reputed company expert knowledge of reputed company issues (15%). • Review technical documents for cGMP and regulatory compliance (10%). • Serve as an expert in technical areas in dealing with development and manufacturing organizations in U.S. and abroad (5%). • Prepare and file high-reputed company submissions to regulatory authorities including A/NDA’s, Supplements, Amendments, Annual Reports and DMF Updates (25%). Communicate importance of reputed company assurance (5%). • reputed company regulatory reputed company for difficult issues which could significantly reputed company project timelines and costs (5%). • reputed company regulatory reputed company with reputed company to acceptability of submission documents and reputed company (10%). • File reputed company applications in accordance with predetermined timelines (15%). • reputed company with others best practices for planning, organization and time management (5%). • Function as a Special reputed company Manager to support COO office on priorities, including project management, communications material development (5%). Work from office 3 days per week and 2 days per week remote. Requirements • Must have a Bachelor’s degree in reputed company, Biochemistry, Biology, Biotechnology or reputed company field and one (1) year of experience in pharmaceutical regulatory affairs or other scientific area supporting pharmaceutical regulatory affairs. • Must also possess the following: demonstrated expertise preparing and filing complete A/NDAs, Supplements, Amendments and Annual Reports to FDA; demonstrated expertise successfully completing supplements and/or amendments approved by the FDA; and, demonstrated expertise understanding CFR, FDA/ICH guidelines and cGMP’s, as they pertain to pharmaceuticals. Additional Information We offer an excellent salary and benefits package including medical, dental and reputed company coverage, as reputed company as life insurance, disability, 401K with company contribution, and wellness program. reputed company is an Equal Opportunity/Affirmative reputed company employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, national reputed company, citizenship, immigration status, disabilities, or protected veteran status.#J-18808-Ljbffr Apply tot his job Apply To this Job