Associate Director, US Regulatory Policy

Company: Novartis Farmac--utica
Location: Rockville
Posted on: April 22, 2025

Job Description:

Associate Director, US Regulatory PolicyJob ID REQ-10046321Mar 28, 2025USASummaryThe Regulatory Policy Associate Director is responsible for supporting the development, implementation, and management of regulatory policies and strategies, while working closely with internal and external stakeholders to navigate the complex regulatory landscape and support the RA organization's strategic objectives.About the RoleKey Responsibilities:

• Monitor regulatory developments and assess their impact on the organization; provide strategic advice to senior management and stakeholders.
• Support regulatory intelligence efforts to identify trends, risks, and opportunities in the regulatory landscape.
• Establish and maintain relationships with regulatory authorities, industry bodies, and key stakeholders.
• Prepare and deliver regulatory reports, presentations, and updates to internal and external stakeholders.
• Support effective communication of regulatory requirements and changes to relevant departments and teams within the organization.
• Collaborate with cross-functional teams to ensure that regulatory considerations are integrated into business planning and decision-making processes. Participate in external working groups in trade associations and other stakeholder groups.
• Develop and present training on new and evolving regulations.Qualifications:

• Education: Science-based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) desirable.
• 4-6 years involvement in regulatory and/or drug/biologic development.
• Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry or health authority.
• Strong problem-solving, analytical and research skills, with the ability to interpret complex regulatory information.
• Strong interpersonal, communication and presentation skills, with the ability to convey regulatory insights to diverse audiences.
• Basic organizational awareness (e.g., matrix interactions, interrelationship of departments, business priorities).Other Skills:
  • Problem Solving Skills.
  • Regulatory Compliance.
  • Drug Development.The pay range for this position at commencement of employment is expected to be between $145,600 and $270,400 /year; however, while salary ranges are effective from 1/1/25 through 12/31/2025, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally.The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.Accessibility & Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.Division DevelopmentBusiness Unit Innovative MedicinesLocation USAState MarylandSite RockvilleCompany / Legal Entity U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
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Keywords: Novartis Farmac--utica, Baltimore , Associate Director, US Regulatory Policy, Executive , Rockville, Maryland