Drug Regulatory Affairs-Assistant Manager Europe

Role & responsibilities

• Regulatory Submission Management: Prepare, review, and submit regulatory documents such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and variations/supplements for injectable drug products in accordance with regulatory requirements.
• Regulatory Strategy Development: Collaborate with cross-functional teams to develop regulatory strategies for injectable drug products, including identifying potential regulatory risks and proposing mitigation strategies.
• Regulatory Compliance: Stay abreast of relevant regulations, guidelines, and industry trends pertaining to injectable drug products and ensure compliance with regulatory requirements throughout the product lifecycle.
• Labeling and Packaging Compliance: Review and approve labeling and packaging materials to ensure compliance with regulatory standards and requirements for injectable drug products.
• Regulatory Documentation Management: Maintain accurate and up-to-date regulatory documentation, including regulatory submissions, correspondence with regulatory agencies, and regulatory intelligence reports.
• Communication with Regulatory Authorities: Serve as the primary point of contact for regulatory agencies regarding injectable drug products, including responding to inquiries, addressing deficiencies, and facilitating interactions during regulatory inspections.
• Cross-functional Collaboration: Collaborate with internal departments such as Research & Development, Quality Assurance, Manufacturing, and Clinical Affairs to ensure alignment on regulatory requirements and timelines for injectable drug products.

Preferred candidate profile

Must have experience in DRA for regulated market.

Perks and benefits