Associate Director, Regulatory Affairs Iberia

hace 1 semana

Barcelona, Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

Location:
Barcelona, Spain

Job reference:
R-191132

Date posted: 02/05/2024

Position Summary


This position is responsible for implementation/execution of regulatory strategies of the products approved and commercialized by Alexion Pharma Spain/Portugal in compliance with the applicable relevant regulations, processes and standards.

This individual will be accountable for provide advise on clinical trial strategy where needed, and possible national scientific advice if relevant.

Will be responsible to provide regulatory excellence for different local processes.

Principal Responsibilities

  • Ensure local regulatory responsibilities are outlined in regulations, policies, and internal standards, aligned with business priorities.
  • Develop and manage innovative and effective regulatory strategies for product registration (and life cycle management ) in Iberia
  • Provide advise on clinical trial strategy where needed, and possible national scientific advice if relevant.
  • Detect and define with RAQ IB D. regulatory priorities on business opportunities and the affiliate's business objectives.
  • Accountable for all interactions with local Health authorities, including health authority meetings, inspections, and other regulatory compliance aspects.
  • Accountable for regulatory compliance of implementation of the risk management plans (RMP) and other postauthorization aspects for the Alexion products.
  • Provide support as local regulatory submissions.
  • Provide local regulatory environment intelligence and advises on expected regulatory hurdles and local specificities, while actively shaping the local regulatory environment for optimal outcomes.
  • Provide expertise to the promotional and nonpromotional reviews and local press releases in collaboration with relevant stakeholders, and accountable for compliance with local legislation.
  • Develop effective collaborations with other functional lines within Alexion Iberia.
  • Collaborate with QA IB all quality management system requirements and ensure regulatory compliance of affiliate to Iberian quality requirements.
  • Mentor less experienced Regulatory team members, ensuring quality and efficiency in the regulatory processes.
  • Provide regulatory excellence for different local processes.

Qualifications

  • At least 15 years of regulatory experience, in pharmaceutical / preferable biotech industry.
  • Proven track record of effective collaboration with "local agencies".
  • Strong Management & leadership ability.
  • Exceptional communication and interpersonal skills.
  • Excellent oral, written, and presentation skills; advanced user of MS Office suite.
  • Through knowledge of global local regulatory requirements and ICH/GCP guidelines.
  • Skilled at project management, with emphasis on time management, organization, and negotiation.
  • Ability to work globally in a matrix environment with Senior Leaders.
  • Ability to influence senior management, peers, and other colleagues without direct reporting lines.
  • Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs.
  • Fluent English language skills.
  • Results
- and compliance-driven; sets standard of excellence for self and others.

  • The duties of this role are generally conducted in an office environment. As is typical of an officebased role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Education

  • Bachelor's degree, preferably in life sciences. Advanced degree (PharmD or PhD) preferred.

Competencies

  • Experience with global and local regulatory and global clinical studies.
  • Experience in rare diseases.
  • Team player who thrives in a teambased environment.
  • Welldeveloped sense of ethics, responsibility, and respect for others.
  • Agile learner with ability to work both collaboratively and independently, seeking advice as required.
  • High level of flexibility and ability to innovate and adapt to changing conditions.

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