Consultant Regulatory Affairs & Publishing

QbD Group; Madrid; Híbrido; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

QbD Group is seeking an experienced Regulatory Affairs professional to join as Consultant Regulatory Affairs & Publishing. Hybrid role based in Madrid or Warsaw, leading submissions across Europe and guiding regulatory strategy for lifecycle management.

You will manage interactions with health authorities, oversee eCTD publishing, and ensure timely updates to SmPC, PIL, and packaging, while mentoring junior staff and shaping regulatory approaches within cross-functional teams.

Formación

• University degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
• Minimum 6-8 years of Regulatory Affairs experience in pharma.
• Experience managing regulatory procedures (variations, renewals, MAAs).
• Strong knowledge of EU legislation and regulatory requirements.
• Hands-on experience with National, MRP, DCP, Centralised Procedures.
• Experience with regulatory strategy development and lifecycle management.
• Knowledge of CTD/eCTD dossier structure and submission requirements.
• Experience with electronic submission platforms like CESP or EMA Gateway.
• Experience communicating with regulatory authorities and handling queries.
• Strong project management with multiple priorities.

Responsabilidades

• Lead and manage regulatory submissions, renewals, and post-approval variations for medicinal products across Europe.
• Develop and implement regulatory strategies to support lifecycle management.
• Serve as regulatory lead for assigned products and advise internal stakeholders.
• Assess regulatory impact of changes and recommend pathways.
• Prepare, review, and coordinate regulatory documentation including Module 1 and eCTD.
• Manage interactions with European and national Health Authorities and respond to questions/deficiency letters.
• Oversee eCTD publishing and submissions.
• Maintain product information (SmPC, PIL, packaging).
• Monitor evolving regulatory requirements and their portfolio impact.
• Support continuous improvement in RA processes and mentor junior staff.

Conocimientos

Regulatory mindset

Project management

Stakeholder management

Analytical ability

Communication skills

Resilience

Curiosity

Innovative thinking

Educación

Pharmacy/Life sciences degree

Herramientas

eCTD publishing platforms (CESP/EMA Gateway)

Descripción del empleo

Consultant Regulatory Affairs & Publishing

Location: Hybrid - Madrid or Warsaw

We are looking for an experienced Regulatory Affairs professional to join our growing team and play a key role in managing regulatory activities for medicinal products across European markets.

This position offers the opportunity to lead complex regulatory projects, contribute to regulatory strategy, and work closely with cross-functional teams and health authorities to support the successful lifecycle management of our product portfolio.

What's in it for you?

Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices

Grow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.

Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.

A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations - because your contribution deserves to be valued.

What you'll be doing

• Lead and manage regulatory submissions, renewals, and post-approval variations for medicinal products across Europe, including National, MRP, DCP, and Centralised Procedures.
• Develop and implement regulatory strategies that support business objectives and ensure compliance throughout the product lifecycle.
• Serve as the regulatory lead for assigned products and provide strategic regulatory guidance to internal stakeholders.
• Assess the regulatory impact of manufacturing, quality, supply chain, and business changes and recommend optimal regulatory pathways.
• Prepare, review, and coordinate regulatory documentation, including Module 1 submissions and eCTD dossiers.
• Manage interactions with European and national Health Authorities, including the preparation of responses to regulatory questions and deficiency letters.
• Oversee eCTD publishing and electronic submissions through applicable submission platforms.
• Ensure compliance and maintenance of product information, including SmPC, PIL, and packaging artwork.
• Monitor and interpret evolving regulatory requirements and assess their impact on the company's product portfolio.
• Support continuous improvement initiatives within Regulatory Affairs processes and systems.
• Mentor and provide guidance to junior team members, sharing expertise and best practices across the organization.

What you bring

• University degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
• Minimum 6-8 years of Regulatory Affairs experience within the pharmaceutical industry.
• Proven experience independently managing regulatory procedures, including variations, renewals, and marketing authorization applications.
• Strong knowledge of EU pharmaceutical legislation and regulatory requirements.
• Hands-on experience with National, MRP, DCP, and/or Centralised Procedures.
• Demonstrated experience in regulatory strategy development and lifecycle management.
• Solid knowledge of CTD/eCTD dossier structure and submission requirements.
• Experience with electronic submission platforms such as CESP, EMA Gateway, or equivalent.
• Experience communicating directly with regulatory authorities and managing regulatory queries.
• Strong project management skills with the ability to manage multiple priorities in a dynamic environment.
• Excellent analytical, organizational, and problem-solving skills.
• Strong stakeholder management and communication skills.

Who you are

Our culture is driven by values If this sounds like you, you'll fit right in:

• You're resilient and tackle challenges with a positive mindset
• You're curious and always up for learning something new
• You have a no non-sense approach honest, clear, respectful
• You're innovative and bring ideas, not just opinions
• And above all, you're serious about your work, but not too serious about yourself

We support life sciences companies from idea to patient - offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.

We believe in JPEG:

Joy. Partnership. Going the Extra Mile. Getting Things Done.

You won't just be taking a job - you'll be joining a community where people grow, laugh, build, and contribute to something bigger.