Director - Regulatory Affairs - CMC & Compliance

1 month ago

Princeton, New Jersey, United States Novo Nordisk Full time

About the Department

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a difference?

The Position

Reporting to the Senior/Executive Director or Vice President of Regulatory Affairs, the Director of Regulatory Affairs – CMC and Compliance will be responsible preparing CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including new marketing applications and supplements. Builds and maintains relationships within the Regulatory Affairs functional areas as well as CMC, product supply and device groups. Manages products and change controls in compliance with regulations and company policies and procedures. Manages assigned projects within assigned resources. Maintain compliance of all internal and external policies and regulations, including a focus on GMP compliance-related activities. May supervise others.

Relationships

Reports to the Senior/Executive Director or Vice President, Regulatory Affairs.

Essential Functions

Provides input into CMC regulatory strategies: define regulatory pathways and milestones for submissions to support development activities leading to successful NDA/BLA approvals.Align CMC regulatory plans with cross-functional development and manufacturing teams.Direct negotiations and manage strategic FDA interactions related to CMC and GMP compliance and related activities.Evaluates proposed manufacturing and quality changes for impact to ongoing and existing filings and provides strategic regulatory guidance for optimal implementation of changes.Facilitates the development of, reviews, and comments on all technically complex CMC documentation for submission to regulatory authorities including documentation for drug substance, drug product and drug/device combinations.Train global functions within regulatory affairs as well as global functions within CMC, product supply and device groups in US specific CMC and compliance requirementsMonitor changes and evolution in the regulatory CMC landscape for products and analyze the impact of changing regulations on assigned projectsManage, train and mentor regulatory affairs personnel Physical Requirements 0-10% overnight travel required. Development of People Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way. QualificationsA Science degree required; advanced degree strongly preferred; doctorate preferredIndustry experience of 12 years, of which at least 7 years spent in regulatory affairs with CMC responsibilitiesPreparing and executing CMC regulatory development strategies in biologics, experience leading successful NDA/BLA submission required, drug delivery device experience preferredExcellent interpersonal, oral, and written communication skills including presentation skillsDemonstrated ability to work in a dynamic environment with a high degree of flexibilityDemonstrated ability to work in a cross functional team and influence the decisions of a teamAbility to successfully prioritize competing work streams simultaneouslyHighest ethical standards, integrity, credibility and character We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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