(Senior) Manager Regulatory Affairs (a)

Depending on the experience level of the candidate, the responsibilities are as follows:

• Coordinate the preparation, submission, management and maintenance of submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: CTAs, amendments and requests for information, Orphan drug applications, Paediatric Investigation Plans and Annual Reports
• Life cycle maintenance activities for marketed products including management information updates and assessment of promotional materials.
• Collaborate with key internal stakeholders to ensure the regulatory strategy is incorporated and implemented in line with product development objectives.
• Assist in coordination and preparation for Agency meetings and associated briefing document preparation.
• Collaborate with cross-functional teams to ensure alignment on regulatory requirements.
• Manage and track queries and commitments with regulatory agencies,collaborate with subject matter experts to respond to queries, provide updates regarding regulatory submissions, conditions/commitments.
• Manages regulatory documents in internal Regulatory Information Management system including tracking submissions and archiving.
• Provide representation for study-level regulatory activities and participate in cross-functional project teams and product development activities/meetings.
• Perform research to support the development of regulatory strategy for the assigned clinical development programs.

International Pharma CompanyTemporary contract with extension option

To be successful in this role, the candidate must have:

• Degree in a life sciences discipline
• 3-5 years' experience in a Regulatory capacity
• Demonstrated experience of contact and relationship with Swiss Medic is an absolute MUST
• Regulatory experience with CTAs and MAAs in Switzerland required
• Good understanding of drug development process and the pharmaceutical healthcare environment including regulatory requirements and policy trends
• Excellent oral and written communications skills in both German and English

• 100% remote work (homebase must be in Switzerland)
• An opportunity to work in a thriving innovative biotech company
• Opportunities to expand your expertise in regulatory affairs