Regulatory Affairs Specialist

Job Type:
Salary Description:
Ref No:

Global pharmaceutical company specialising in oncology therapies is currently looking for a

a Regulatory Submission Specialist to join a busy team and support all tasks related to new products submission and existing products.

Key tasks:

* Perform and coordinate submission of pre- and post-authorization regulatory

activities, such as clinical trial applications (CTAs), new marketing

authorization applications (MAAs) and lifecycle management activities,

including but not limited to renewals, variations, PSURs etc.

* Prepare regulatory affairs submission according to requirements of the

relevant authorities (EMA, EU National Competent Authorities, Swissmedic


* Prepare electronic applications in eCTD format in support of the company’s

regulatory activities,

* Liaise with the regulatory authorities to ensure timely assessment, linguistic

review and approval.

* Perform document management tasks including file transfer, storage,

tracking, and archival of regulatory submission documentation.

* Apply company style guide formatting requirements to create submission

ready documents that are compliant with internal and heath agency


* Provide regulatory operations guidance and information to Regulatory Affairs

department and submission project teams in relation to eSubmission and

procedural guidance.

* Assist in the mentoring and training of Regulatory and cross-functional team

members; prepare and maintain training materials.

Professional skills and experience:

* 2-4 years regulatory experience
* Bachelor’s degree preferred; Equivalent experience within the Regulatory

operations function will be considered

* Knowledgeable in regulatory procedures (CTAs, MAAs and post-authorization

submissions) in MRP / DCP and centralized procedures

* Knowledgeable in CTD/eCTD structure and requirements and firm

understanding of submission requirements for EU submission types

* Proficiency in publishing and compilation of eCTD submissions, eCTD

validation and viewing tools (knowledge of eCTDmanager is a plus)

* Proficiency in MS Word and Adobe Acrobat; strong formatting skills and use

of templates.

* Ability to work independently (with minimal supervision) as well as work in a

team environment with changing timelines and priorities.

This is a permanent role in Geneva region. The company offers exciting projects to work on and great opportunities for growth and development.

Please send your CV

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.

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