Regulatory Affairs Consultant
Duration: 03/11/2025 to 30/06/2026
Location: Zug
Responsible for the management of regional regulatory affairs activities for biosimilars, overseeing a centralized authorization. Coordination with affiliate RA to identify and complete national regulatory requirements, enable product launches, and manage product updates across countries. Focus on building, maintaining interfaces with internal stakeholders, vendors, affiliate RA, and medical team, facilitating national regulatory process steps, such as risk minimization measures.
Key Responsibilities
* Develop and implement regulatory strategies for specific projects and programs.
* Identify and assess regulatory risks with support from senior team members.
* Coordinate and prepare regulatory documents and submission dossiers with affiliate RA.
* Manage development and maintenance of additional Risk Minimization Measures (aRMMs).
* Support regional labeling activities and regulatory CMC as needed.
* Monitor and report on registration project progress to ensure timely approvals and launches.
* Provide regulatory support and effective communication across functions.
* Build and maintain relationships with internal and external stakeholders, including vendors, partners, and regulatory authorities.
* Ensure regulatory compliance for assigned compounds/products.
* Stay updated on regional legislation relevant to the company.
* Comply with internal policies and procedures.
* Provide training and support to affiliate RA colleagues.
Key Requirements
* Bachelor's degree in pharmacy, chemistry, biology, pharmacology or related life sciences subject.
* 3-5 years' experience in pharmaceutical/biotechnology industry or in scientific research preferred with at least 1 year experience in Regulatory Affairs.
* Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements.
* Ability to work independently with minimal direction and within project teams.
* Demonstrate organisational skills, including the ability to prioritise workload.
* Good interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
* Effective cross-cultural awareness and capabilities.
* Some experience in interfacing with relevant regulatory authorities.
* Knowledge and understanding of applicable regulations and regulatory pathways.
* Some experience in interpretation of regulations, guidelines, policy statements, etc.
* Sensitivity for a multicultural/multinational environment.
* Detail oriented with effective written and oral communication skills.
* Fluent verbal and written English skills.
SThree_Germany is acting as an Employment Business in relation to this vacancy.
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