Job Description

Join to apply for the Associate Regulatory Affairs Director role at myGwork - LGBTQ+ Business Community

1 day ago Be among the first 25 applicants

Join to apply for the Associate Regulatory Affairs Director role at myGwork - LGBTQ+ Business Community

This job is with AstraZeneca, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Associate Regulatory Affairs Director

Introduction to role

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARAD provides regulatory expertise and guidance on procedural and documentation requirements to all collaborators and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives globally.

Accountabilities

Lead and/or contribute to the planning, preparation, and delivery of both simple and complex submissions throughout the product's life cycle.

Drive and lead delivery-focused teams, e.g., GRET (Global Regulatory Execution Team) on a product level or RSDT (Regulatory Submission Delivery Team) for major submissions (MAA/NDA).

Assume overall accountability for the planning, forecasting, and reporting, applying refined project and stakeholder management skills, ensuring optimized delivery of regulatory activities to time and quality.

Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:

Submission delivery strategy of all dossiers and all application types per market and/or region.

Review documents and provide regulatory input (e.g., response documents, high-level documents, study protocols, PSRs, etc.).

Analysis of regulatory procedures and special designations used during development, authorizations, and extension of the product.

Identify regulatory risks, opportunities, and proactively develop mitigation strategies for operational regulatory activities, e.g., planned submissions (with input from all team members).

May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.

As a member of the Regulatory Affairs Manager community, the ARAD will:

Be a recognized expert in the current regulatory environment.

Understand the regulatory framework, including regional trends for various types of applications, procedures, and documents, in both small and large molecules with a particular focus on planning, delivery, and project management.

Provide coaching, mentoring, and knowledge sharing within the RAM skill group.

Contribute to process improvement.

Essential Skills/Experience

Bachelor's degree in science or a related field with 5+ years of regulatory experience within the biopharmaceutical industry or health authority

Thorough knowledge of drug development

Strong project management skills

Leadership Skills, Including Experience Leading Multi-disciplinary Project Teams

Excellent written and verbal communication skills

Cultural awareness

Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions

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

Desirable Skills/Experience

Proficiency with common project management (e.g., MS Project) document management tools and Veeva Vault/ERV

Managed complex regulatory deliverables across projects/products

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are committed to turning our drug development strategies into reality. Our work spans across varied stages of development, allowing us to translate life-changing science into medicines that make a real difference for patients in need. We thrive on innovation and embrace challenges that push us beyond traditional regulatory approaches. Our collaborative environment values diverse perspectives, empowering us to influence drug development strategies and achieve efficient approvals. By joining our team, you will be part of a dynamic group that is dedicated to making impactful contributions to healthcare.

The annual base pay (or hourly rate of compensation) for this position ranges from $135,182-$202,773. 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.

Start date : ASAP

Salary : Negotiable

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at myGwork - LGBTQ+ Business Community by 2x

Get notified about new Associate Director Regulatory Affairs jobs in Gaithersburg, MD .

Rockville, MD $161,279.04-$232,958.61 1 month ago

Rockville, MD $125,439.25-$170,238.98 1 month ago

Tysons Corner, VA $161,279.04-$232,958.61 1 month ago

Arlington, VA $125,439.25-$170,238.98 1 month ago

Washington, DC $125,439.25-$170,238.98 1 month ago

Washington, DC $161,279.04-$232,958.61 1 month ago

Arlington, VA $161,279.04-$232,958.61 1 month ago

Arlington, VA $161,279.04-$232,958.61 1 month ago

Arlington, VA $125,439.25-$170,238.98 1 month ago

Tysons Corner, VA $125,439.25-$170,238.98 1 month ago

Director, Deputy General Counsel - Enterprise Compliance Officer

Director, Legal, Technology & Commercial

Senior Director, Legal, Ethics & Compliance

Senior Director of ITC, Compliance and Legal

Senior Managing Counsel, U.S. Public Sector

VICE PRESIDENT AND ASSOCIATE GENERAL COUNSEL

Washington, DC $245,000.00-$255,000.00 1 month ago

Director and Counsel, Sanctions & Antiboycott (Hybrid)

Senior Vice President (SVP) and General Counsel

Senior Director and Associate General Counsel - Corporate Governance

Director, International Satellite Policy and Compliance

Washington, DC $225,000.00-$275,000.00 1 week ago

Vice President & Senior Legal Counsel, Global Compliance

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

Job Tags

Hourly pay, Full time, Temporary work, Work at office, Immediate start, Flexible hours, 3 days per week,

Similar Jobs