Associate Director – Regulatory Affairs

Job Description: • Responsible for developing and executing global regulatory strategies for assigned projects and programs. • Support development of the preclinical and clinical development plan. • Identify and assess regulatory risks associated with product development. Define mitigation or contingency strategies. • Set strategic direction and leads global regulatory submission process with submission teams, including IND, CTA and core briefing packages. • Prepare and/or lead global regulatory submissions including IND, pre-IND meeting package, CTA. • Mentor Regulatory Managers. • Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position. • Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development. • Provide input to Senior Management teams. • Maintain a global view as part of the whole regulatory team. Requirements: • BA/BS/University degree, Life/Health Sciences preferred. • 8 years pharmaceutical/biotechnology industry experience with technical management experience. • Minimum of 6 years in RA. • Comprehensive knowledge of applicable regulations. • Experience in interpretation of regulations, guidelines, policy statements, etc. • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements. • Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project. • Knowledge of regulations governing the development of drugs. • Solid knowledge of GCPs and GLPs. • Direct experience in interfacing with relevant regulatory authorities (FDA). • Foster effective, positive interactions with regulatory agencies, and corporate partners. • Ability to lead and influence project teams, committees, etc. to attain group goals. • Demonstrate excellent leadership and communication skills. • Ability to represent the department in project teams, committees and external meetings. • Demonstrate strong organizational skills, including the ability to prioritize personal workload. • Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff. • Strong sensitivity for a multicultural/multinational environment. • Experience leading multi-disciplinary teams. • Well organized, detail oriented, effective written and oral communication skills. • Supervisory/mentoring experience. • Ability to guide, train, supervise and prioritize workload of direct reports if applicable. • Expert knowledge and experience in gene therapy highly desirable. Benefits: • Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays + 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation Apply Now Apply Now