Associate Director, Sr Regulatory Affairs Clinical Strategist US

279687BR
Associate Director, Sr Regulatory Affairs Clinical Strategist US
Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

Job Description

750 million. That’s how many lives are touched by Novartis products globally. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

What you’ll bring to the role:

The Sr. Regulatory Affairs Clinical Strategist, US drives the development and implementation of globally aligned, regional regulatory strategies that deliver timely approvals of AAA products and line extensions in the US with optimal product labelling. Builds and maintains excellent working relationships with FDA as FDA liaison. Ensures full regional regulatory compliance. Is a core member of select global project teams in R&D.
Regulatory Strategy:
• Directs the development and implementation of regulatory strategies (non-CMC) for US, including proactive identification of regulatory risks / options, ensuring globally aligned negotiation and mitigation strategies for assigned development compounds (registration) and marketed products (life cycle management) in the AAA portfolio:
• Provides strategic input to identify regulatory pathways for complex radiopharmaceutical products used for both, diagnosis and therapy, in a continually evolving regulatory environment.
• Provides strategic input, review and approve clinical study protocols, including clinical protocols for US investigator initiated studies, and protocol amendments.
Health Authority Interactions
• Prepares globally aligned meeting materials for FDA meetings.
• Leads meetings with FDA.
• Contributes to and reviews responses to HA questions for preclinical and clinical aspects, including responses to FDA compliance e.g. questions regarding field alerts or safety reporting, to ensure appropriate, consistent and complete answers to any HA questions. Ensures responses are in line with global development strategy.
• Establishes and maintains strong relationship with FDA.
Submissions and Approvals
• Leads US submission planning process (preclinical and clinical part) for assigned projects, including planning process for potential Advisory Committees.
• Responsible for ensuring full regional compliance with all US regulatory obligations / regulations.
• Supports alignment with and support of market access needs in US and assigned regions.
Labeling
• Supports development of Target Product Profile for assigned development projects, especially in view of US approved products.
• Supports creation of US product information based on approved global labeling document for assigned projects.
• Ensures appropriate maintenance of US labeling documents for assigned projects, including QC and format compliance.
Regional Excellence and Compliance
• Ensures full compliance with US regulatory requirements for product maintenance.
• Supports writing and maintenance of SOPs.
• Supports organization of appropriate archiving for US regulatory submissions and supports identification and implementation of document management system.

At Advanced Accelerator Applications we believe the answers are found when highly agile and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore transformative innovation. Where you’re empowered to push boundaries/create innovation/challenge assumptions by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at AAA! Start your career conversation today
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Minimum requirements

Bachelors or Masters in scientific discipline. (MD, Ph D, PharmD) preferred
Minimum 5 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV in most or all of the following areas:
Innovation in regulatory strategy.
Prior history with post-marketing/brand optimization strategies and commercial awareness
Major involvement in a CTD/MAA/NDA submission and approval.
Leadership role in HA negotiations in the US.
Proven success in global drug regulatory submissions.
Proven ability to analyze and interpret efficacy and safety data.
Regulatory operational expertise.
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.
Additional language is an asset.
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
USA
East Hanover, NJ
AAA USA Inc.
Research & Development
Full Time
Regular