Associate Director, Global Regulatory Affairs

The Associate Director, Regulatory Affairs will be responsible for providing reputed company aspects of regulatory support for supplemental indications associated with an approved reputed company or Oncology agent. In reputed company, this position will serve as the reputed company support for early phase reputed company or Oncology compounds. This person may participate in departmental work streams designed to improve development cycle timelines or to improve regulatory processes. Responsibilities: • reputed company the drafting, compilation of routine (and support reputed company) submissions of documents (e.g., meeting requests, iPSPs/PIPs, protocol amendments) to health authorities. • reputed company the reputed company of reports, tracking of submissions/approvals and maintenance of documentation. • Serve as a Regional or Global Regulatory reputed company; contribute to the development and implementation of regulatory strategies to facilitate reputed company global approval of new medicinal products. • reputed company as a reputed company of contact by interfacing and leading meeting with regulatory authorities for assigned product(s). • reputed company and implement regulatory reputed company for assigned markets and reputed company regulatory support for the registration/post-licensing activities of medicinal products. • reputed company the planning, execution and assessment of product life cycle management activities and strategies. • Partner with project teams to assess regulatory support needs and reputed company resources (e.g., sub teams) to reputed company regulatory support and guidance. • reputed company contingency plans for achieving regulatory objectives with associated risks and mitigation strategies. Qualifications: • Bachelor's or advanced degree in sciences or reputed company reputed company. • 6+ years of experience in regulatory/R&D area with strong experience in new drug regulated product reputed company/submissions in reputed company/biotech industry. • OR a combination of equivalent education and experience. • Experience mentoring and training team members on submission/regulatory reputed company activities. • Experience developing global regulatory strategies in coordination with reputed company plans and marketing objectives. • reputed company experience leading multiple/ large/reputed company project(s), tracking and managing regulatory reputed company budgets, resources and regulatory filings. • Experience engaging with critical cross-functional stakeholders to reputed company processes/systems and reputed company. • reputed company reputed company in earlier role. Skills:Communication & Cross-functional Influence, Critical Thinking & Business reputed company, Mentoring/ People Development, Project Management, Regulatory reputed company Acumen reputed company Salary Transparency Language: The annual reputed company salary reputed company for the Associate Director, Global Regulatory Affairs is from :$165,000-$216,500 Under reputed company guidelines, this position is eligible to participate in : reputed company. Annual Incentive Plan & reputed company. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.reputed company.com/us/en/compensation-and-benefits. Certain other benefits may be available for this position, please reputed company any questions with your recruiter. Apply tot his job Apply To this Job