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Regulatory Affairs Specialist

Regulatory Affairs Specialist

About us

Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners created in response to the unmet need for manufacturing of gene therapies. Our goal is to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world.

We are excited for our next Regulatory Affairs Specialist to join the Viralgen team!

About the role

We are seeking a Regulatory Affairs Specialist who will play a key role on the structure of the company in validation and regulation process required by Agency and regulatory authorities.

The job involves the authoring and review of CTD sections for MAAs, BLA, variations, DMFs, IMPDs & INDs and their submission to regulatory agencies according to specific EMA and FDA Gene Therapy guidelines, whilst also working closely within cross-functional teams to deliver the CMC packages on time, with the assistance of the Head of Regulatory Affairs, the Plant Director and the Quality Assurance group.

Responsibilities

  • CMCs elaboration &/or review.
  • INDs and DMF elaboration &/or review.
  • Design and control the contractual and regulatory documentation for client’s documentation.
  • Submission of documentation through regulatory agency applications. Be update with the applicable legislation and regulation.

About you

  • Pharmacist, Chemical Engineer, Biologist or similar Universitary Degree.
  • Solid experience of more than 7 years in the pharmaceutical world, with knowledge of the regulatory requirements for Advanced Therapies and the quality documentation required for clinical trial and marketing authorisation applications.
  • Solid experience as Regulatory Affairs Specialist in a Big Pharma.
  • Fluent English.
  • Proactive management and positive attitude to change and challenges.
  • Communication skills.
  • You are self-motivated and used to work in a multidisciplinary environment.