We are looking for a dynamic, capable, curious, and innovative person to join our Regulatory Affairs (RA) team.

• Coordination of new MAAs and dossiers’ management until its closure, managing the deficiency letters coming from Authorities.
• Integrating all related activities for national phases submission, such as translations of product information with national consultants and mock-ups creation with design departments, and close follow-up with authorities until MA is granted.
• Ensuring that any condition to the marketing authorization is completed.
• Organizing AWs development according to internal procedures and digital tools to be added to the company’s master file in close interaction with launch timelines.
• Compile and prepare any involved documentation required for variations - administrative, quality or safety related ones- in liaison with internal policies and/or proper partners.
• Assisting Competent Authorities and/or vendors on general lifecycle management activities until its approval.
• Updating of AWs portfolio after regulatory activities’ approval guarantying that implementation date is respected and shared with AWs and Supply Chain departments.
• Submitting renewals in timely manner and ensuring timelines are shared with relevant parties and in every market.
• Archiving of essential documents, such as Product Information, approved mock-ups, letters of approvals and updated AWs in regulatory server.
• Make sure that the regulatory database is up to date for every product and marketing authorization to fulfill xEVMPD obligations.
• Monitoring sunset clause to be avoided.
• Informing interested parties on the regulatory status for current portfolio based on internal procedures.
• Stay up to date on latest regulatory requirements in Europe and share potential impact to the involved parties.
• Managing eCTD documents.

Innovation, results orientation, communication, teamwork, adaptability/flexibility, self-development, sense of urgency, initiative.

• Education: Degree in Health Sciences (preferably Pharmacy, but also Chemistry, Biology, Biochemistry, Veterinary or similar).
• Languages: Fluent English is a must.   

• Experience (years/area): 3-4 years of experience in the mentioned functions above within a regulatory department of a pharmaceutical industry.
• Specific Knowledge: Knowledge of eCTD structure for preparation of module 1 and CMC expertise. Experience in portfolio management in connection with generics or branded generics (copies) for decentralized procedures.  Awareness or regulatory affairs environment, EU-wide legal framework, and European authorities’ websites.

• Personal skills: Effective communication both verbally and in writing.