Regulatory Affairs Specialist - Remote

About the job

We are seeking a highly motivated and detailoriented immediate joiners Regulatory Affairs specialist to join our consulting company. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development approval and marketing of pharmaceutical products globally (internationally).

Responsibilities:

Submission and Approval Process:

Preparation and submission of Manufacturing License Application (MLA)

Preparation and submission of Technical/Site Transfer Applications

Preparation and submission of Marketing Authorisation Applications

Lifecycle Maintenance:

Preparation and submission of documentation for postapproval applications including but not limited to Variations Renewals MAH Transfers/COAs Labeling

Compliance:

Monitor and maintain uptodate knowledge of national European and International guidelines/legislation

Ensuring compliance with all regulatory processes in readiness for both internal and external audits

Ensuring compliance with the regulations of the assigned Countries within European and International Regions

Communication:

Act as a liaison between the pharmaceutical company and the regulatory agencies

Support internal requests for information

Experience:

58 years of relevant experience in Regulatory Affairs Internationally

Lifecycle maintenance experience

Experience with: MLA MAA CTD Variations Renewals Labeling Applications

Experience working with Global Market

Experience with software packages and databases (Microsoft Office Suite Veeva Vault (or comparable EDMS) LorenZ Trackwise PromoMat etc.)

Good organizational skills and communication skills

Ability to prioritize and deliver highquality work

Experience in people management/coordination is a plus

Experience in promotional/nonpromotional activities is a plus

Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

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Remote Work :

No