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Almirall

Global biopharmaceutical company focused on dermatology

Regulatory Affairs Senior Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeReinbek, Germany

About the Job

Requirements

  • A completed degree in Life Sciences, Pharmacy, or a comparable natural science field (B.Sc. or M.Sc.).
  • At least 7 years of professional experience in Regulatory Affairs, particularly with global regulatory submissions and communication with health authorities.
  • Strong knowledge of ICH guidelines, eCTD structure, and regional regulatory requirements in the United States, Europe, and other international markets.
  • Project management skills, regulatory document preparation skills, and ability to collaborate across functions and influence stakeholders.
  • Strong written and spoken communication skills and stakeholder management capability.
  • Ability to identify regulatory risks early, assess options, and make clear recommendations.
  • Ability to develop pragmatic and innovative solutions to complex regulatory issues.
  • Ability to work with international cross-functional teams and external partners.

Responsibilities

  • Develop and implement global regulatory strategies and plans, and maintain regulatory roadmaps and risk registers.
  • Lead preparation of IND, IMPD, and CTA submissions, variation applications, briefing materials, and major marketing authorization applications.
  • Coordinate health authority meetings and responses to health authority inquiries, ensuring consistent, high-quality communication.
  • Advise CMC, nonclinical development, and clinical development teams on regulatory requirements and documentation standards.
  • Own labeling strategies and manage post-approval variation procedures.

Desired Qualifications

  • Further qualification beyond the stated degree is advantageous.
  • Experience with accelerated approval procedures and scientific advice procedures.
  • Experience in the regulatory environment for small molecules, biologics, and advanced therapies.
  • Experience with inspections, audits, and due diligence processes.

About the Company

Almirall

Global biopharmaceutical company focused on dermatology

Almirall develops and markets dermatology medicines for conditions such as psoriasis, actinic keratosis, atopic dermatitis, and acne, with global R&D and manufacturing capabilities. Its products are created through its R&D center, plants, and partnerships and then distributed through 15 affiliates to over 100 countries. The company differentiates itself with a long history (since 1944), an integrated global footprint, and a patient-centric approach that involves listening to patients and working with healthcare networks. Its goal is to transform patients’ lives by helping them achieve a healthy life through dermatology-focused innovations and broad global access to treatments.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Barcelona, Spain
Founded
1943

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