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Senior Regulatory Affairs Director, Global Regulatory Strategy

2 months ago

Boston, United States AstraZeneca Full time
Job Description

Do you have expertise in, and passion for, Regulatory Affairs? Would you like to apply your expertise and channel the scientific capabilities in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you

At AstraZeneca, we are using cell therapy to revolutionize the treatment of life-threatening immune-mediated diseases. We put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

AstraZeneca’s pipeline of innovative medicines is growing within Immunology Cell Therapy , one of our major therapy areas. To meet the increasing demand of regulatory expertise, we continue to expand our regulatory functions through the recruitment of Regulatory Affairs Strategists(at Director and Senior Director level). You will work across disciplines in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.

The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy will be responsible for overseeing the development and implementation of global regulatory strategies for assigned products in the Cell Therapy Immunology area, with the intention of achieving successful registration and lifecycle management to serve patient needs.

This individual will, with a high sense of urgency, lead cross-Regulatory teams and be accountable to provide key regulatory input to Global Project and Franchise Teams (GPTs/GFTs) deliverables. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

You will be responsible for:

  • Providing regulatory strategic oversight for products and/or projects in the relevant therapeutic areas/portfolio, as assigned, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
  • Lead and support staff in preparation for regulatory authority meetings and provide input to submission strategy and other critical regulatory documents. May represent Astra Zeneca as point contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.
  • Provide input to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
  • Actively collaborate with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide portfolio or therapeutic level regulatory insight and broader drug development expertise.
  • Actively be up to date on latest regulatory requirements and trends.
  • Can provide support as needed to Business Development activities of the Enterprise, notably supporting Regulatory due diligence, gap assessment and resource needs.
  • Ensure exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.

Essential for the Role:

  • Bachelor’s Degree in a scientific or pharmaceutical discipline
  • 10+ years of Regulatory experience in the pharmaceutical industry, with significant track record on Global Strategies.
  • Strong knowledge of drug development and regulatory policy in immune-mediated diseases or other complex therapy areas, coupled by excellent scientific and business judgment.
  • Experience providing strategic regulatory advice for the global development of products in several major jurisdictions such as EU, US, China, Japan through all stages of development including pre-approval and marketed assets.
  • Successful track record in registering and overseeing regulatory strategies for assets.
  • Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
  • Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management.
  • Strong interpersonal, and written/verbal communication skills.
  • Proven track record practicing sound judgment as it relates to risk assessment
  • Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information.
  • Experience in cell therapy development is a plus

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.

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 ready to bring new ideas and fresh thinking to the table? Brilliant We have one seat available and we hope it’s yours.

Where can I find out more?

Date Posted

18-Jul-2024

Closing Date

29-Aug-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.