Regulatory Affairs Manager III

JOB TITLE: Regulatory Affairs Senior Manager, Biosimilars Business Unit

SUMMARY:
Responsible for leading regulatory affairs activities for assigned projects and programs and for leading affiliate RA to identify and complete national regulatory requirements for assigned projects and programs, to support commercialisation. Responsible for collaboration and relationship management with the strategy of the company and vendors for assigned products. Responsible for regulatory documents, submissions, and compliance issues. Influences stakeholders to ensure deliverables are in line with technical standards, quality, and timelines. Drives innovative process change for improved efficiency across regulatory processes and requirements. Monitors and provides notification of changes in requirements as well as assessing the impact of agency guidance updates relevant to technical aspects of submissions. Provides training to project teams on requirements and expectations on regulatory systems and processes for GxP document management.
Represent the company with regulatory authorities, contractors, and corporate partners. Provide regulatory support for various departments, projects, and teams/committees.

REQUIREMENTS:
- 6 to 8+ years pharmaceutical/ biotechnology industry with 4 to 6+ years regulatory experience
- SME in regulatory processes
- Good knowledge of applicable regulations, and submission standards/ requirements. Ability to interpret regulations and guidelines.
- Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements
- Strong communication and project management abilities in global and virtual teams
- Strong interpersonal skills and the ability to collaborate effectively across project teams, innovator business and with vendors.
- Ability to work independently with minimal supervision
- Competent in the use of electronic document management tools.
- Flexibility, proactive, attention to detail, demonstrated accountability for deliverables, and proven ability to work independently is expected.
- Demonstrate strong organizational skills, including the ability to prioritize personal workload and to manage a large volume of complex tasks.

Contact: Alba Jansa

Whatsapp : +41 76 811 63 99

+ 41 61 282 22 13