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23 Sept 2026 | Madrid, Spain

ServiceUpdated on 10 September 2026

Regulatory Affairs & Market Authorization Support

Business Development & Marketing Senior Officer at Owlpharma - Consulting, Lda.

Lisboa, Portugal

About

Owlpharma's Regulatory Affairs Department provides full-spectrum regulatory support to pharmaceutical and healthcare companies, guiding products through every stage of the regulatory lifecycle. From early regulatory strategy and dossier preparation to marketing authorization submissions and post-approval maintenance, our experts help organizations navigate complex regulatory requirements efficiently and compliantly.

Our services include:

  • Development Phase Support

    • Review and preparation of Marketing Authorisation (MA) dossiers

    • Regulatory strategy development for MA approval

    • Conversion of dossiers to eCTD format

  • Pre-Marketing Authorisation Activities

    • Preparation, submission, and management of MA applications in EU and non-EU markets

    • Local representation as Marketing Authorisation Holder (MAH)

    • Pricing and reimbursement applications

    • Regulatory support for product launch and commercialization

    • MA dossier audits

  • Post-Marketing Authorisation Support

    • Preparation, submission, and management of variations and renewals

    • Drug information management through the EudraVigilance platform (XEVMPD)

    • Regulatory review and support for advertising and promotional activities

Type

  • Consulting

Applies to

  • Pharmaceutical industry

Organisation

Owlpharma - Consulting, Lda.

Consultancy

Coimbra, Portugal

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