Associate Director, Global Regulatory Affairs - Pharma job in Fort Worth
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
This role will support our Dry Eye and Ocular Health Surgical Diagnostics portfolio. This position serves as a regulatory liaison on the project team throughout the product life cycle. The main purpose of this position is to develop and implement global regulatory strategies to secure global market access for the assigned Franchise portfolio, in line with business objectives, and in coordination with key internal and external stakeholders. |
•Sets mid-range objectives for assigned projects in Franchise, and sets near term objectives for Alliances and BD regulatory support.
•Determines and pursues courses of action necessary to meet the organization's objectives and schedules.
•Directs and coordinates activities concerned with research and development of projects.
•Directs the development of submission of drug product registration, progress reports, supplements, amendments, and/or safety reports (PSUR, PADERs). Ensures that pre-clinical and clinical trials designs meet regulatory requirements.
•Participates in drug development plan, regulatory strategy, risk management, implementation plan, chemistry manufacturing and control (CMC).
•Provides Regulatory Affairs support for the assigned Franchise to the Therapeutic Unit Head and to Business Development and Alliances.
•Creates, maintains, and obtains alignment on Franchise global regulatory strategy in close collaboration with Regulatory Management.
•Leads and coordinates all regulatory aspects of Development, Alliances, and Business Development activities for the Franchise.
•Develops and maintains effective relationships with regulatory authority staff at management level, and with key outside specialists in the area that Alcon uses as experts for regulatory dossiers and agency meetings.
•Aligns strategic guidance across the project teams in the assigned portfolio.
•Provides regulatory guidance and deliverables.
•Runs an effective and efficient regulatory sub-team, a matrix team that includes all functions needed to execute the accountabilities of the member.• Bachelor's Degree or equivalent years of directly related experience (high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
• The ability to fluently read, write, understand and communicate in English
• 7 Years of Relevant Experience
• 5 Years of Demonstrated Leadership Experience
•Strong knowledge of global drug regulatory requirements including clinical, non-clinical and safety reporting (PADER, PSUR, Safety Labeling)
•Strategic thinking and strong problem solving skills
•7 years of pharmaceutical industry experience is preferred but not required. •6 years of regulatory experience (or combination of 8 years regulatory and/or related experience) is preferred but not required.