662. Head of Regulatory Affairs – Director/a de Asuntos Regulatorios

Job Title: Head of Regulatory Affairs – Director/a de Asuntos Regulatorios
Location: Madrid. Spain
Reports To: Chief Operating Officer (COO) or General Manager

Reiwa Healthcare S.L. (www.reiwahealthcare.eu) is a young Spanish pharmaceutical company (Laboratorio Titular de Autorizaciones de Comercialización) with Marketing Authorizations in the following European countries: Spain, Germany, Portugal and Hungary.

Job Summary

The Head of Regulatory Affairs will handle all regulatory operations within the company. The person will be responsible for managing and coordinating all regulatory activities required to obtain and maintain product approvals with health authorities. This role works closely with internal and external teams to ensure compliance with local and international regulations, facilitating the commercialization of pharmaceutical products within applicable regulatory frameworks.

Key Responsibilities

– To prepare (mainly m1), review (from m2 to m5), and submit regulatory new dossiers for registration through National Procedures or through DCP.  Whilst the dossier is initially drafted by our Asian colleagues team, Reiwa Healthcare’s RA is in charge of a deep revision of all the sections applying a critical eye on the strategy and proposing experienced CMC revisions according to ICH and EU regulations with the aim to  avoid as many deficiencies and future variations as possible. A close, fluent and effective coordination with Asian team is mandatory.
– To keep accurately updated the regulatory database(s) and records as well as technical documentation related to all the pharmaceutical products portfolio.
– To ensure compliance with European regulatory requirements throughout the product lifecycle. To monitor changes in regulatory legislation and guidelines, assessing their impact on the company and proposing action plans.
– To feed the Pharmacovigilance database from a regulatory point of view and collaborate with Pharmacovigilance team as requested.
– To organise, plan and prepare, regulatory packages for renewals, variations, and post-approval changes.
– Daily collaboration with departments such as R&D, Quality Assurance, Manufacturing, Pharmacovigilance, and Commercial teams to ensure regulatory compliance.
– To give support from a regulatory perspective to audits and to respond to possible inquiries from Health Authorities.
– To prepare, review and update product information, product labelling, and promotional materials in compliance with current regulations.
– To contribute to regulatory strategy for new product registrations and market access.

Qualifications and Skills

Educational Background: Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related scientific field.
Experience: Minimum of 5 years in the pharmaceutical industry working as Regulatory Affairs Specialist or similar position with a deep experience in preparing and submitting regulatory dossiers. Familiarity with regulatory tools and submission platforms (such as eCTD manager, CESP, etc..).
Regulatory Knowledge: Knowledge of local and international regulatory guidelines and procedures. In-depth understanding of EU-GMP, Spanish regulatory requirements, and CMC
Project Management: Strong project management skills with a track record of managing complex projects across multiple functions.
Communication Skills: Excellent written and verbal communication skills in both Spanish and English.

Key Competencies

Analytical Thinking: Ability to analyse complex issues, identify solutions, and make data-driven decisions.
Problem Solving: Proactive approach to identifying issues and implementing corrective actions.
Collaboration: Ability to work effectively with cross-functional teams and communicate clearly with stakeholders.
Compliance-Oriented: A commitment to maintaining the highest levels of regulatory compliance and product integrity.
Attention to Detail: Ability to detect mistakes with strong attention to detail and commitment to quality and compliance.

Benefits

Competitive salary with performance-based incentives
Professional development and continuing training opportunities
Working flexibility with smart working most of the weekly days.