Global Program Regulatory Director job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
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. 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 English 10 years directly related experience
Science based BS or MS with requisite experience and demonstrated
capability. Advanced degree (MD, Ph D, PharmD) preferred.
Languages: Fluency in English as a business language. Additional language is an asset.
Experience: Minimum 6-8 years of regulatory and drug/biologic development
experience, ideally spanning activities in Phases I-IV in most or all of the
Innovation in regulatory strategy.
Prior history with post-marketing/brand optimization strategies and
Major involvement in a CTD/MAA/NDA submission and approval.
Leadership role in HA negotiations in multiple regions.
Proven success in global drug regulatory submissions.
Proven ability to analyze and interpret efficacy and safety data.
Regulatory operational expertise.
Minimum 2-5 years of demonstrated leadership and accomplishment in
all aspects of regulatory affairs in a global/matrix environment in the
Global matrix management people management experience desirable.
Good management, interpersonal, communication, negotiation and
problem solving skills.
Organizational awareness (e.g., interrelationship of departments,
business priorities), including experience working cross functionally and
in global teams.
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