Regulatory Affairs Manager - Iberia

Regulatory Affairs Manager - Iberia
         
CH Regulatory Affairs Iberia – Regulatory Affairs Manager

Position

Regulatory Affairs Manager – Iberia

Main purpose

Responsible for regulatory management, strategic ownership and lifecycle execution for an assigned portfolio within Iberia, covering medicinal products, herbal medicinal products and other relevant product categories including cosmetics, medical devices and food supplements.

As a member of the Iberia Regulatory Affairs team, provides regulatory guidance to local business stakeholders and regional/global functions across Spain and Portugal on regulatory strategy, processes, risks, market-specific requirements, authority expectations and local implementation needs.

Serves as an RA contact and regulatory subject matter expert for the assigned portfolio across Iberia, escalating material risks, issues and recommendations to Iberia RA leadership as appropriate.

Scope

Iberia: ES, PT and PALOP markets as applicable

Key figures

- Direct reports: 0
- Managed positions: 0
- Financial figure: to be confirmed; assigned portfolio sales to be aligned with relevant Iberia category/sub-portfolio planning assumptions.

Key tasks & responsibilities

- Develop, own and implement regulatory strategy and lifecycle plans for assigned categories and brands within Iberia, in line with agreed local, cluster and regional priorities.
- Prepare, coordinate and support submissions, variations, renewals, PSURs, authority responses, labelling, artwork, local text updates, CMC updates and implementation activities for the assigned portfolio.
- Maintain medicine dossiers, medical device technical files, food supplement and cosmetic documentation for the assigned portfolio according to applicable statutory requirements.
- Provide regulatory advice to Spain and Portugal business stakeholders on launches, claims, product changes, artworks, portfolio activities and local implementation topics.
- Identify regulatory risks, issues and options for the assigned portfolio, escalating material recommendations to Iberia RA leadership as appropriate.
- Collaborate within the country, cluster, regional and global organization to resolve product-related issues and support risk management activities for assigned categories and brands.
- Liaise with Spanish and Portuguese health authorities and other competent bodies for assigned topics, in coordination with relevant Iberia, regional or global colleagues.
- Act as the local Regulatory Affairs representative for Portugal at relevant Portuguese trade association regulatory committees, and represent Bayer in Spanish or wider Iberian trade association activities where appropriate, ensuring alignment with Iberia RA strategy and agreed business priorities.
- Monitor Spanish, Portuguese, Iberian and relevant European regulatory developments impacting the assigned portfolio and ensure appropriate communication, mitigation and implementation follow-up.
- Maintain accurate regulatory information, tracking tools, reporting and databases for the assigned portfolio, ensuring compliance obligations are met.
- Prepare, review, maintain and archive regulatory documentation and correspondence to a high-quality, right-first-time standard.
- Provide RA input to inspections, quality investigations, complaints, recalls, shortage notifications and CAPA activities as required.

Key working relations

Internal

- Country, Cluster, Regional and Global Regulatory Affairs teams.
- Iberia Regulatory Affairs leadership and category stakeholders.
- Local BCH departments, including Commercial, Marketing, Medical, Drug Safety, Quality, Supply, CDH and other relevant business functions in Spain and Portugal.

External

- Health Authorities and competent bodies in Spain, Portugal and PALOP markets as applicable.
- Portuguese trade association regulatory committees, where the role acts as local RA representative; Spanish and wider Iberian industry associations and regulatory committees as appropriate.
- External experts, consultants and service providers as appropriate for assigned activities.

Qualifications & competencies

- Education: scientific degree, such as PhD, PharmD or equivalent qualification.
- Experience: typically 3–5 years of experience in Consumer Health Regulatory Affairs or related Regulatory Affairs roles, preferably within the pharmaceutical industry.
- Hands-on experience with regulatory submissions, lifecycle management, labelling/artwork activities and operational regulatory delivery.
- Knowledge of Portuguese national and European regulatory requirements for medicinal products is mandatory ; knowledge of Portuguese requirements for medical devices, food supplements and/or cosmetics and Spanish regulatory requirements is desirable.
- Experience working cross-functionally with teams across countries and functions, including local business stakeholders and regional or global regulatory colleagues.
- Demonstrated ability to develop and execute regulatory activities for an assigned portfolio, supporting business objectives while ensuring appropriate governance, compliance and escalation of risks.
- Competencies : Execution Excellence, Consumer & Customer Focus, Business Acumen, Team Player, Problem Solving, Attention to Detail, Commercial Awareness and Adaptability.
- Communication Skills : ability to explain complex scientific and regulatory topics in an understandable way and connect them to business impact.
- Language Skills: professional fluency in Portuguese and English ; Spanish language capability is desirable for broader Iberia collaboration.

Application Period: 30/09 - 15/10 Reference Code: 889973       Division: Consumer Health     Location: Spain : Cataluña : Barcelona       Functional Area: Regulatory Affairs     Position Grade: VS 1.1       Employment Type: Regular  Work Time: Full Time       Contact Us   Address Telephone E-Mail
Av. Baix Llobregat, 3, 08970 Sant Joan Despí,
Barcelona, Espanya
+34  93 495 69 99 [email protected] (mailto:[email protected])