Associate Director, Global Regulatory Affairs- Distributor Management
Associate Director, Global Regulatory Affairs- Distributor Management

Associate Director, Global Regulatory Affairs- Distributor Management

Cambridge Full-Time 43200 - 72000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead regulatory activities for in-market partners across diverse regions.
  • Company: Join Gilead, a leader in global health innovation and regulatory excellence.
  • Benefits: Enjoy competitive pay, career growth opportunities, and a supportive work culture.
  • Why this job: Make a real impact on global health while collaborating with passionate professionals.
  • Qualifications: Bachelor’s in Health or Pharmaceutical Sciences; significant regulatory experience required.
  • Other info: Gilead values diversity and is committed to equal employment opportunities.

The predicted salary is between 43200 - 72000 £ per year.

Associate Director, Global Regulatory Affairs – Distributor Management, Cambridge This is an exciting opportunity for an Associate Director, Regulatory Affairs to join Gilead\’s Global Regulatory Affiliates & Distributor team. The role involves overseeing regulatory activities of in-market partners in the GPS region (South Asia, South-East and Central Asia, and Africa). The position requires effective stakeholder management, collaboration with regional leadership, cross-functional teams, and in-market partners. The main goal is to ensure regulatory activities meet Gilead’s standards and align with commercial priorities. The role covers countries in Central and East Africa, including Botswana, Ethiopia, Malawi, Mauritius, Mozambique, Namibia, Uganda, Zambia, and Zimbabwe. Key Responsibilities: Manage regulatory capabilities of in-market partners, including due diligence, onboarding, and training. Oversee legal agreements impacting regulatory activities. Develop and propose regional and national regulatory strategies. Support product launch activities and resolve emerging regulatory issues. Provide regulatory insights and contribute to regional meetings and external engagements. Core Competencies: Experience in international regulatory affairs and submission processes. Knowledge of ICH and regional regulatory requirements. Ability to lead cross-functional teams and develop regulatory strategies. Excellent communication skills in English and interpersonal skills. Education & Experience: Bachelor’s degree in Health or Pharmaceutical Sciences. Significant regulatory affairs experience, including working with regulatory agencies and dossier preparation. Strong relationship-building and leadership skills. Additional Information: Gilead is committed to equal employment opportunity and prohibits discrimination based on protected characteristics. #J-18808-Ljbffr

Associate Director, Global Regulatory Affairs- Distributor Management employer: Gilead Sciences International, Ltd.

Gilead is an exceptional employer that fosters a collaborative and inclusive work culture, making it an ideal place for professionals in the regulatory affairs field. Located in Cambridge, employees benefit from a vibrant community and access to cutting-edge resources, while also enjoying opportunities for personal and professional growth through ongoing training and development. With a commitment to innovation and excellence, Gilead empowers its team members to make a meaningful impact in global health.
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Contact Detail:

Gilead Sciences International, Ltd. Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Associate Director, Global Regulatory Affairs- Distributor Management

✨Tip Number 1

Familiarise yourself with the regulatory landscape in the GPS region, especially the specific requirements for countries like Botswana and Uganda. This knowledge will not only help you understand the role better but also demonstrate your commitment to the position during interviews.

✨Tip Number 2

Network with professionals already working in regulatory affairs within the pharmaceutical industry. Attend relevant conferences or webinars to connect with potential colleagues and gain insights into current trends and challenges in the field.

✨Tip Number 3

Prepare to discuss your experience in managing cross-functional teams and how you've successfully navigated regulatory challenges in the past. Be ready to provide specific examples that highlight your leadership and problem-solving skills.

✨Tip Number 4

Stay updated on Gilead's recent activities and product launches in the GPS region. Understanding their commercial priorities will allow you to align your responses during interviews and show that you're genuinely interested in contributing to their goals.

We think you need these skills to ace Associate Director, Global Regulatory Affairs- Distributor Management

International Regulatory Affairs Expertise
Knowledge of ICH Guidelines
Understanding of Regional Regulatory Requirements
Stakeholder Management
Cross-Functional Team Leadership
Regulatory Strategy Development
Excellent Communication Skills
Interpersonal Skills
Regulatory Dossier Preparation
Legal Agreement Oversight
Training and Onboarding Experience
Problem-Solving Skills
Product Launch Support
Relationship-Building Skills

Some tips for your application 🫡

Understand the Role: Take time to thoroughly read the job description for the Associate Director position. Understand the key responsibilities and core competencies required, as this will help you tailor your application to highlight relevant experiences.

Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in international regulatory affairs, particularly any work with regulatory agencies and dossier preparation. Use specific examples to demonstrate your ability to manage regulatory capabilities and lead cross-functional teams.

Showcase Communication Skills: Since excellent communication skills are essential for this role, ensure that your application reflects your ability to communicate effectively. Use clear and concise language, and consider including examples of how you've successfully engaged with stakeholders or led meetings.

Tailor Your Cover Letter: Craft a personalised cover letter that addresses Gilead specifically. Mention why you are interested in this role and how your background aligns with their mission and values. Make sure to connect your skills and experiences directly to the responsibilities outlined in the job description.

How to prepare for a job interview at Gilead Sciences International, Ltd.

✨Understand the Regulatory Landscape

Familiarise yourself with the regulatory requirements specific to the regions you'll be overseeing, especially in Central and East Africa. This knowledge will demonstrate your commitment and readiness to tackle the challenges of the role.

✨Showcase Your Stakeholder Management Skills

Prepare examples of how you've effectively managed stakeholders in previous roles. Highlight your ability to collaborate with cross-functional teams and regional leadership, as this is crucial for success in the position.

✨Demonstrate Leadership Experience

Be ready to discuss your experience in leading teams and developing regulatory strategies. Share specific instances where your leadership made a significant impact on project outcomes or team dynamics.

✨Prepare for Scenario-Based Questions

Anticipate questions that may require you to solve hypothetical regulatory issues or develop strategies for product launches. Practising these scenarios will help you articulate your thought process and problem-solving skills effectively.

Associate Director, Global Regulatory Affairs- Distributor Management
Gilead Sciences International, Ltd.
Location: Cambridge
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