Senior Associate, Regulatory Affairs

2 meses atrás

Lisboa, Portugal Biogen Tempo inteiro

**Job Description**:
The Regulatory Affairs Senior Associate will perform regulatory related activities in the Portuguese Affiliate, with accountability to the Quality & Governance Manager who has the area oversight.

The Regulatory Affairs Senior Associate acts as backup of the Qualified Person, according to the local regulations and as backup contact for QA topics within the organization and to external bodies (e.g., National Health Authority - Infarmed).

The Regulatory Affairs Senior Associate supports the local Affiliate Governance activities related with procedures developing and process improvement for regulatory, quality areas and, if needed, for other departments. This role acts as Functional Learning Liaison, namely within R&D QMS system.

**Principal Accountabilities**

**Regulatory**
- Translation, review & approval of source text for country labelling and artworks.
- Review and approval of promotional and non-promotional materials.
- Understand and applies legal and trade industry code of conduct requirements for promotion of medicinal products.
- Act as Super User for Materials Review Tool.

**Quality**
- Receives and manages contacts from external stakeholders regarding technical product complains, distributors related complains and product returns from customers, and administratively handles these situations accordingly with Biogen requirements.
- Performs Deviations, Planned Exception, CAPA, Change Control and Risk Assessment related activities.
- Acts as backup of the Responsible Pharmacist in the following activities:

- Review QP release documentation and ensure that shipping temperature conditions and expiry date follow the regulatory national requirements and, consequently, perform local administrative release.
- Handle aspects related with Quality System.
- Management of returns between Biogen and logistics partners: approving or rejecting any returns into saleable stock in accordance with national law.
- Management of destruction of Finished Goods in accordance with National Law.
- Develop and maintain local quality agreements.
- Act as the local coordinator of Product Recall, participate in Recall Committee when impacted product is distributed in the country.
- Act as the local coordinator of Product Supply Shortages.
- Local Quality Management System (QMS) development, namely contributes to improvement of quality system, complete and evaluates quality indicators and trend reports.
- Coordination and alignment with Regional Manager.

**General Governance**
- In collaboration with Q&G Sr Manager ensures that local Regulatory and Quality requirements are correctly captured in local procedures and aligned with corporate guidance; support Local Procedures Life Cycles in myCIMS.
- Builds business processes where necessary.
- Collaborate in Audits/ Inspections (as needed).

**Qualifications**:

- Degree in Master in Pharmaceutical Sciences.
- Member of the Portuguese Pharmaceutical Society.
- Experience in Regulatory and Quality activities (minimum of 3 years’ experience).

Additional Information
**Why Biogen?**
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

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