Intern Global Regulatory Affairs Development Strategy
Detail de l'annonce :
TITLE: INTERN GLOBAL REGULATORY AFFAIRS DEVELOPMENT STRATEGY (GRA-DS)
REPORTS TO: ASSOCIATE DIRECTOR, GRA-DS, META+ THERAPEUTIC AREA
LOCATION: LEVALLOIS-PERRET, FRANCE
Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca
focused on rare diseases, created following the 2021 acquisition of
Alexion Pharmaceuticals, Inc. As a leader in rare diseases for nearly
30 years, Alexion is focused on serving patients and families affected
by rare diseases and devastating conditions through the discovery,
development and commercialisation of life-changing medicines. Alexion
focuses its research efforts on novel molecules and targets in the
complement cascade and its development efforts on haematology,
nephrology, neurology, metabolic disorders, cardiology and
ophthalmology. Headquartered in Boston, Massachusetts, Alexion has
offices around the globe and serves patients in more than 50
countries. More information about Alexion can be found at:
www.alexion.com.
POSITION SUMMARY
The intern will provide support in the execution of various regulatory
activities in line with the agreed regulatory strategy for the Meta+
portfolio products, leading to successful registration and life-cycle
management of unique and technologically complex products serving
patients with rare diseases and unmet medical needs. The individual
will also ensure effective communication and constructive working
relationships with internal partners and representatives of regulatory
authorities.
PRINCIPAL RESPONSIBILITIES
• Works Global Regulatory lead (GRL) and Regulatory Sub team to
execute regulatory activities.
* Prepares and submits Clinical Trial Applications to National
European Competent Authorities.
* Provides support in the preparation of Scientific Advice,
pre-submission and marketing authorization applications
* Monitor the development of new regulatory requirements or guidance
documents and advise product teams of the impact on the business or
development programs
* Provides support to regulatory affairs reviewers for due diligence
initiatives.
* Ensures exemplary behavior, ethics and transparency within the
company and with regulatory agencies
QUALIFICATIONS
• Basic knowledge in clinical development
* Dynamic and able to build working relationship, good team player
and computer
SKILLS
• Strong interpersonal and written/verbal communication skills.
* Ability to multi-task, pay close attention to detail, and follow
projects through to
completion to meet deadlines;
EDUCATION
• Student in Pharmacy or equivalent scientific degree (5+ years),
with a preference with Master's Degree in Regulatory Affairs
* First experience in the pharmaceutical or other related industry
COMPETENCIES
• English both written and oral
* Microsoft Office Pack (profficient)