Global Regulatory Affairs Specialist

7 giorni fa

Milano, Lombardia, Italia Jefferson Wells Italia A tempo pieno

Jefferson Wells, per conto di un'importante azienda farmaceutica, è alla ricerca di un Global Regulatory Affairs Specialist.

SCOPO DEL RUOLO:

Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global regulatory strategies, with particular reference to EU. This role involves preparing regulatory dossiers, coordinating with health authorities, ensuring product registration, and providing regulatory guidance to cross-functional teams.

RESPONSABILITA'

Regulatory Submissions & Documentation


• Prepare, compile, and submit global regulatory dossiers

for new marketing authorization applications (MAAs),

variations, renewals


• Ensure timely and accurate submission of documents in

compliance with global regulations.


• Support the labelling and change control processes to

ensure timely and comprehensive review and approval of

all packaging components (e.g., cartons, labels,

Physicians Insert, Patient Insert, and Medical Guides).


• Maintain high-quality regulatory documentation, ensuring

it is consistent, accurate, and compliant with the

regulatory requirements in different regions.

Regulatory Compliance & Strategy


• Support the development and implementation of global

regulatory strategies for assigned products in

collaboration with internal teams to ensure product

approval across multiple markets.


• Monitor regulatory changes and industry trends to ensure

compliance with evolving guidelines and support the

updating of regulatory strategies.


• Advise cross-functional teams (R&D, Quality Assurance,

Manufacturing, etc.) on regulatory requirements and

strategies for market approval/ lifecycle management.


• Contributes to the creation and maintenance of the

Regulatory Affairs quality system collaborating to the

definition of processes and implementation of global

standard procedures


• Maintain knowledge of global regulatory requirements

and trends, sharing relevant updates with internal teams.


• Contribute to regulatory intelligence activities and provide

insights into global regulatory landscape developments.


• Track regulatory submissions, approvals, and regulatory

activities using tracking systems and ensure timely

reporting to management

Requisiti


• Good knowledge of EMA, ICH and FDA regulations, guidelines, and regulatory processes regarding to drug development, approval, and maintenance of marketing authorisations.


• Strong organisational skills
• Good commercial and product awareness.


• Sound administrative and systems background.


•Minimum 3 years of experience in Regulatory Affairs in the Pharmaceutical Industry.


• Master Degree in scientific subject, preferrable in Pharmacy or related. Master in Regulatory Affairs is considered a plus.


• Fluent in English, spoken and written


• Master of Office


• Familiarity with eCTD submission, compilation and publishing using specific tools.

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