Regulatory Operations Associate Jobs in Silver Spring, MD

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management experience and a track record of advancing innovative therapies through key clinical development milestones. As a key member of the global regulatory strategy team (GRST), you are responsible for partnering with senior regulatory experts to support the end-to-end regulatory strategy planning, coordination, and execution of assigned cell therapy projects. The ARAD is solutions-oriented and a key contributor to regulatory strategy development, the identification of submission risks and opportunities, and drives high quality global regulatory authority engagements and submissions. The ARAD provides regulatory expertise and guidance on the clinical development requirements, including procedural and documentation requirements to regulatory and cross-functional teams, working flexibly within and across regions to achieve business objectives.

Accountabilities/Responsibilities

• Partner closely with members of the global regulatory team, to define stage appropriate regulatory strategy in alignment with global regulatory requirements and expectations, to bring innovative cell-based gene therapies to patients.
• Closely monitor evolving global and regional regulatory guidelines, policies, and procedures to support efficient, scientifically rigorous, and patient-centric development plans.
• Lead and contribute to the planning, preparation, review, and submission of regulatory submissions (e.g., IND, CTA, GMO, BLA, IVDR) s for cell-based gene therapies across all regions, ensuring proper documentation and compliance with internal and external standards.
• Advise the regulatory and cross-functional teams of available opportunities to accelerate development by evaluating risks and identifying potential solutions to address regulatory hurdles.
• Participate in meetings withHealth Authoritiesto gain direct exposure to regulatory feedback and enable:
  • Contribution to submission delivery strategies for all dossiers and application types that are responsive to health authority advice
  • Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Support some operational and compliance activities for assigned projects.
• May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
• Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management skill group.
• Contribute to governance meetings and process improvement.

Minimum Requirements

• Bachelor's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field

• 5+ years of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience

• Thorough Knowledge of drug development

• Strong project management skills

• Leadership skills, including experience leading multi-disciplinary project teams

Preferred Experience

• Master's, PharmD, or PhD degree in Science, Regulatory Sciences, Pharmacy, or another related discipline

• 7+ years of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience

• Managed complex regulatory deliverables and submissions across projects/products
• Managed CTA or first wave Marketing Applications and/or LCM submissions with application of IVDR/GMO
• Knowledge of AZ Business and processes
• Experience and expertise using Artificial intelligence tools

Skills and Capabilities

• Excellent written and verbal communication skills
• Cultural awareness
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
• Proficiency with common project management (e.g., MS Project) and document management tools
• Ability to work independently and as part of a team
• Influencing and stakeholder management skills
• Ability to analyze problems and recommend actions
• Continuous Improvement and knowledge sharing focused

Internal and External Contacts/Customers

• Global Regulatory Leads (GRLs)
• Regional Leads (eg, US, EU international RADs)
• Lead RPM
• Regulatory skill group in CGT
• Marketing Companies
• Health Authorities
• External Collaboration partners

Why AstraZeneca?

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next?

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you!

The annual base pay for this position ranges from $135,624.80 - $203,437.20 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional 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 pay (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.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.