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Regulatory Affairs Management Director, Regulatory Science & Execution, Dublin
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Client:
Alexion Pharmaceuticals
Location:
Dublin, Ireland
Job Category:
Other
-
EU work permit required:
Yes
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Job Reference:
6a48e12d0e6c
Job Views:
4
Posted:
01.06.2025
Expiry Date:
16.07.2025
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Job Description:
This is what you will do:
The Regulatory Affairs Management Director (RAD), Regulatory Science & Execution will be responsible for leading a team of regulatory affairs managers (RAMs) to develop and implement regulatory strategies for assigned products and regulatory jurisdictions, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
This individual will, with a high sense of urgency, lead a team of RAMs to provide operational and strategic regulatory input to cross-functional teams responsible for executing programs in relevant regulatory jurisdictions. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
You will be responsible for:
Leading a team of RAMs to develop and implement regulatory strategies for products and/or projects in the relevant regulatory jurisdictions, as assigned, aligned to overall Enterprise objectives and global regulatory strategies through initial registration and subsequent lifecycle management.
Providing advice and input to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
Actively collaborating with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight and broader drug development expertise.
Actively being up to date on latest regulatory requirements and trends .
Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization where required.
Work with cross functional and other regulatory partners to proactively identify areas of risk and improvement, as applicable.
Drive knowledge management by sharing case studies/lessons learned from regulatory activities within the Regulatory Science & Execution.
Ensuring exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.
You will need to have:
Qualifications
10+ years of Regulatory experience in the pharmaceutical industry, with experience in regional regulatory strategies.
Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgment.
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.
Demonstrated ability to lead, mentor, and motivate team members to achieve organizational goals
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 in relevant areas and solid understanding of where to seek and how to interpret regulatory information.
Education
Bachelor’s Degree, life science highly desirable
Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus
Additional certification and/or training relevant to the role
Competences
Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint
Proficient in English in the Corporate setting. Additional languages are a plus
Date Posted
10-Feb-2025
This is what you will do:
The Regulatory Affairs Management Director (RAD), Regulatory Science & Execution will be responsible for leading a team of regulatory affairs managers (RAMs) to develop and implement regulatory strategies for assigned products and regulatory jurisdictions, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
This individual will, with a high sense of urgency, lead a team of RAMs to provide operational and strategic regulatory input to cross-functional teams responsible for executing programs in relevant regulatory jurisdictions. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
You will be responsible for:
1. Leading a team of RAMs to develop and implement regulatory strategies for products and/or projects in the relevant regulatory jurisdictions, as assigned, aligned to overall Enterprise objectives and global regulatory strategies through initial registration and subsequent lifecycle management.
2. Providing advice and input to internal Governance and advisory bodies from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
3. Actively collaborating with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight and broader drug development expertise.
4. Actively being up to date on latest regulatory requirements and trends .
5. Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization where required.
6. Work with cross functional and other regulatory partners to proactively identify areas of risk and improvement, as applicable.
7. Drive knowledge management by sharing case studies/lessons learned from regulatory activities within the Regulatory Science & Execution.
8. Ensuring exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.
You will need to have:
Qualifications
9. 10+ years of Regulatory experience in the pharmaceutical industry, with experience in regional regulatory strategies.
10. Strong knowledge of drug development and regulatory policy, coupled by excellent scientific and business judgment.
11. Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
12. Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management.
13. Demonstrated ability to lead, mentor, and motivate team members to achieve organizational goals
14. Strong interpersonal and written/verbal communication skills.
15. Proven track record practicing sound judgment as it relates to risk assessment
16. Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GxPs in relevant areas and solid understanding of where to seek and how to interpret regulatory information.
Education
17. Bachelor’s Degree, life science highly desirable
18. Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus
19. Additional certification and/or training relevant to the role
Competences
20. Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint
21. Proficient in English in the Corporate setting. Additional languages are a plus
Date Posted
10-Feb-2025
Closing Date
09-Mar-2025Our 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. #J-18808-Ljbffr