International Regulatory Affairs Manager
Secteur : Industrie du médicament humain Famille de fonction : Affaires réglementairesDescription du poste et des missions
Descriptif du poste:
The Regulatory Affairs Manager (RAM), International Regulatory Affairs will be responsible for planning, preparing and executing regulatory activities for assigned project(s)/product(s) and jurisdiction(s), 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, provide operational regulatory input to cross-functional product/project teams, including Alexion affiliates and AstraZeneca marketing companies to execute regulatory deliverables that support the geographic expansion and maintenance of the portfolio. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
You will be responsible for:
Responsible for in collaboration with Local Regulatory, to plan and prepare regulatory submissions in the International region, overseen by the International Regulatory Leads (IRLs) to deliver on business objectives for assigned products/programs.
Responsible for supporting the local regulatory submission lead on assigned submissions in planning, coordination, compilation, and delivery of Regulatory documents according to plan.
Actively contributes to the planning and conduct of regulatory authority interactions in relevant jurisdictions, providing execution support to the International Regulatory Leads and other key stakeholders (e.g. Country Regulatory Affairs).
Responsible for assuring that assigned regulatory activities are performed according to current regulatory internal and external requirements in the relevant jurisdiction(s).
Supports the International Regulatory Lead in internal Governance and advisory bodies, or other relevant internal activities, including on the development and management of select Regulatory processes and procedures, as well as inspection/audit support.
Actively collaborates with other Regulatory teams and Enterprise functions (e.g. Commercial, Medical) to provide regulatory input to business-relevant deliverables concerning the International region.
Actively be up to date on and efficiently apply latest regulatory requirements and trends, within assigned jurisdiction and regulatory focus area (e.g. clinical development, lifecycle management).
Ensure exemplary behavior, leadership, ethics and transparency within the Enteprise, with Health Authorities and other external stakeholders.
You will need to have:
Qualifications
4+ years of relevant Regulatory experience in the pharmaceutical industry.
Strong knowledge of drug development and regulatory policy, couple by excellent scientific and business judgment.
Experience managing regulatory activities in International markets for the global development of products through one or several stages of development including pre-approval and marketed 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.
Strong interpersonal, and written/verbal communication skills.
Proven track record practicing sound judgment as it relates to risk assessment
Understanding of GxPs at 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 over the past
Competences
Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint
Experience working in regulatory documentation system (like Veeva).
Proficient in English in the Corporate s
Profil souhaité:
Expérience requise:
