520 million! That is the number of patients our products reached in 2019. At Sandoz, we discover new ways to improve and extend people’s lives.
The Associate Director, Regulatory Affairs will be responsible for PDMA compliance and regulatory approval of all digital therapeutic product line marketing and professional material, selling documents and promotional materials through PRC.
The Associate Director will also be responsible for interpreting pre-clinical/clinical trials, data collection, pharmacology, toxicology, drug metabolism, and clinical research in support of 505(b)(2) applications. Facilitate and support the due diligence and co-development of compounds through the various stages of clinical research; collaborate with all disciplines within the Company. Help prepare quality documents for submission to regulatory agencies to permit the legal distribution of pharmaceuticals for clinical or commercial purposes.
•Responsible for preparation/supervision of preparation of regulatory submissions, including INDs, NDA [505(b)1 & 2], supplements, amendments, and variations, 510(k), IDE and PMA. •Responsible for PDMA compliance and regulatory approval of advertising and promotional materials through PRC •Responsibilities will include interaction with FDA and other regulatory agencies throughout the development of projects, including support for regulatory agency meetings, teleconferences, Advisory Committee meetings, etc. •Production of associated records of regulatory meetings will be required along with the preparation of briefing documents. •This individual will also be responsible for researching and the review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings, to support the development of optimal regulatory strategies to support the successful submissions and achievement of target product labeling. •Identify and evaluate complex problems where analysis of situations or data requires an in-depth evaluation of various factors. •Participate in due diligence activities for potential licensing and acquisition opportunities that are being evaluated by the company.
What you'll bring to the role:
•BA/BS in biological or pharm science related field •Advanced Degree- MS/PhD/PharmD preferred •Minimum of 8 years of experience in Regulatory Affairs specialized in clinical regulatory and toxicology. •Knowledge of regulatory requirements, guidances and regulations (US) within the pharmaceutical industry, specific to the area of clinical research, product development and labeling. •Experience with 505(b)(2) (NDA) submissions is required. •Detail oriented, well organized, and good planning skills •Excellent written and verbal communication skills •Supervisory experience a plus
Why consider Sandoz? Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Join us, and help reimagine access to medicine.
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.