Regulatory Affairs Biosimilars Manager

hace 2 semanas

Barcelona, España Winid A tiempo completo

**Winid** is a game-changer that puts TALENT SOURCING at the heart of its business model.

We firmly believe that talented people are the crucial element for the success of organizations. We understand it as Augmented Talent by putting technology and AI at the service of people.

We aim to reach excellence in attracting, training, and equipping the finest talent acquisition consultants globally.

**About the client**:
Is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing companies in the world.

The RA Manager for biosimilars will coordinate the regulatory affairs activities with the Headquarters in India for all related Biosimilars products pre and post-approval phase, in regulated markets worldwide.

**Responsibilities**:

- Understands Biosimilars EU/US regulations and guidance.
- Provide regulatory support to the internal R&D team and external customers during the development program and product life cycle
- Collaborate closely with Regulatory CMC on related filing content, strategies, and risk mitigations.
- Assist during the Dossier Due Diligence process with potential third-party
- Regulatory point of contact for third-party clients.
- Regulatory compliance check of documents and evaluation of change controls
- Maintain compliance for assigned products (PSURs, HA correspondence, product label updates, adhering to SOPs )
- Provide RA support to the BD department
- Internally interact with different stakeholders to coordinate and ensure successful product launches.
- Coordinate QTA and SDEA discussions with clients

**Relevant Professional / Educational Background**:

- University degree in a scientific discipline (Pharmacy, Biology, Chemistry, etc)
- A Master’s degree in the Pharmaceutical industry and/or regulatory affairs is preferred
- Minimum of 5 years experience in Regulatory Biosimilars
- Experience in global matrix environment preferred
- Knowledge of Quality Assurance and Pharmacovigilance is preferred
- Advanced written and spoken English

**Core Competencies**
- Strong organization skills, and ability to prioritize workload independently
- Good verbal and written communication skills
- Action-oriented
- Drive for results
- Customer Focus

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