Associate Director, Regions Global Regulatory Affairs

Location
Bannockburn, IL, US
Posted
Sep 09, 2020
Ref
5505
Hotbed
BioMidwest
Required Education
Doctorate/PHD/MD
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Associate Director, Regions Global Regulatory Affairs, partners with key stakeholders internally in Novartis Gene Therapies (GTx) and Novartis, and externally with Competent Authorities to fulfill business objectives, by securing earliest high quality approvals in Wave 2 and 3 countries and through to life cycle management, by maintaining registrations compliant and up to date throughout the product life cycle.

Responsibilities
  • Collaborates with GTx global and Novartis regional and country regulatory affairs teams.
  • Acts as business partner for key regional stakeholders including but not limited to clinical, medical, pharmacovigilance, quality affairs, supply chain, market access, and commercial.
  • Ensures regulatory strategies are developed and executed for all assigned products and territories.
  • Oversight of RA filings for submission and approval of Marketing Authorization applications, and life-cycle management activities.
  • Ensures a global approach to regulatory strategy and decision-making, including close collaboration across all regulatory functions for the assigned products and territories.
  • Develops and implements regional regulatory project strategies.
  • Provides regional strategic regulatory input for lifecycle management of products, throughout the development and lifecycle value chain.
  • Develops and supports implementation of processes, procedures and organizational changes to improve efficiency and quality.
  • Establishes strong strategic partnership with the commercial function to ensure development of international regulatory strategies for the assigned products and territories that are consistent with business priorities.
  • Represents and/or supports the Regulatory Lead in representing the regulatory affairs for regions team on cross-functional teams (e.g., National Country Launch Teams/ Regional cross-functional teams/ clinical study teams).
  • Leads in the interaction with regional regulatory agencies during product development/registration in Wave 2 and 3 countries and during lifecycle management of registrations; in close collaboration with NVS affiliates.
  • Plans, leads and implements regulatory submissions (MAAs, CTAs, local submissions, etc.) in collaboration with the other disciplines (e.g., Affiliates, Emerging Markets and Regional Affiliates).
  • Uses persuasion and negotiation skills to effectively lead cross-functional groups in the completion of project tasks.
  • Encourages input from sub-team members and issues global strategic plans as necessary.
  • Ability to effectively negotiate basic regulatory agreements with Health Authorities.
  • Prepares and presents written and oral reports and other presentations to internal and external audiences, including senior management and global health authorities. Demonstrates the flexibility to adjust presentation style and content to suit the audience.
  • Directs and manages the preparation and review of technical strategic regulatory documentation for agency submission.
  • Attends agency meetings for the assigned products and territories such as key policy meetings, major filing or strategy meetings relevant to assigned project.
  • Directs and/or provides input into interactions with agency reviewers.
  • Monitors actual vs. planned activities and timelines. Identifies and recommends improvements to correct or accelerate project progression.
  • Ensures processes are in place to provide regulatory input and approval to international clinical programs, including regulatory review of clinical trial documents and submissions.
  • Identifies risk areas and develops alternative courses of action including anticipation of regulators' responses through scenario planning and development of contingency plans with affiliate input.
  • Self-initiates project assignments.
  • Coaches and mentors team members and staff across multiple, diverse projects.
  • Other related job duties as assigned.

Qualifications
  • Bachelors' degree in scientific discipline with 9 years relevant experience ( increasing responsibility in the pharmaceutical industry (can be a combination of regulatory and R&D related experience)); Master's degree with 7 years relevant experience or PhD/PharmD (preferred) with 5 years relevant experience.
  • Sound basis of Scientific (Training/Communications) knowledge
  • Expert understanding of pharmaceutical/biotech organizational processes and procedures in the Global Regulatory Affairs function and experience with developing processes, procedures and organizations to improve efficiency and quality.
  • Expert understanding of pharmaceutical clinical development plans, regulatory requirements, and their impact on the development of clinical trials and MAAs /BLAs.
  • Able to write clearly and succinctly in a variety of communication settings; open, transparent and excellent communication skills, both verbal and written.
  • Experience in developing and managing regulatory submissions, including vendor and distributor management.
  • Demonstration of being proactive, engaged in problem solving, creative, and preferably a strategic ability beyond simple project management.
  • Demonstrated organizational and collaboration skills.
  • Ability to deliver professional and quality work products while working on multiple projects.
  • Proficient in use of Microsoft Office and eCTD related software systems.
  • Expert risk management skills
  • Experience with rare diseases preferred


The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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