Experis® is a global leader in professional resourcing, permanent recruitment, project solutions, and managed services. With over 25 years of experience in Switzerland and offices in Zürich, Basel, and Geneva, we connect top Pharma talent with leading companies.
We are looking for a Regulatory Affairs Manager who will be responsible for the management of regional regulatory affairs activities for biosimilars, over and above a centralized authorization. Coordination with affiliate RA to identify and complete national regulatory requirements to enable product launches. Management of product updates across countries. The focus of this multifaceted role is on building, maintaining and managing multiple interfaces with internal stakeholders, vendors, the affiliate RA responsible person and medical team, facilitating and overseeing national regulatory process steps, such as risk minimization measures.
Accountability Description:
* Responsible for managing the development and implementation of regulatory strategy for specific projects and programs. Contribute to identification and assessment of regulatory risks associated with product development with support from senior team members.
* Responsible for managing the coordinating and preparation of regulatory documents and submission dossiers, in close collaboration with affiliate RA for specific products. Manage the development and maintenance of aRMMs and support regional labelling activities for specific products, and provide support to regulatory CMC as needed.
* Responsible for oversight and reporting on registration project progress to enable timely approval, implementation and launch activities.
* Effectively communicate and provide regulatory support across functions for specific projects.
* Build and maintain effective relationships with internal and external stakeholders, including the interface with vendors, corporate partners, and regulatory authorities as needed. Provide guidance and support to ensure regulatory compliance for the assigned compounds/products.
* Gain and maintain an active awareness of regional legislation in areas of interest to the company. Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of Biogen.
* Provide training and support to affiliate RA colleagues.
Education:
* 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
Knowledge & Skills:
* 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 good communication skills.
* 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.
* Good verbal and written English skills.
If you are interested in this opportunity, please apply with a copy of your CV.
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