Experienced Regulatory Affairs Manager (Pharma) 50%-100% (f/m/d) at HEMEX AG

le contenu du travail

HEMEX is committed to changing the future of healthcare by guiding the most promising European startups through each and every step to bring innovative pharmaceuticals, medical devices, and in vitro diagnostics to the market. Headquartered close to the thriving Basel global Life Sciences hub, the goal at HEMEX is to ensure startups have access to a wide range of tailored services, practical solutions, and fundraising support.

This empowers the next generation of transformative discoveries to grow into successful and sustainable businesses, and drive change in both human and animal healthcare.

Tasks

Regulatory Affairs Manager

• University degree in Life Sciences, Pharmaceutical, Medical Sciences, or related discipline.
• At least 10 years’ experience in the EU and/or the US, in the pharmaceutical and biologics industry.
• Excellent knowledge of international regulatory standards in the areas of pharmaceutical quality, safety, and efficacy.
• Experience in CMC writing advantageous.
• Experience in market access and pricing advantageous.
• Ability to adapt communication style based on audience and situation.
• Ability to coordinate and network with various stakeholders simultaneously.
• Proactive in identifying potential issues and escalating them accordingly.
• Solution finder with the ability to deal with complex information.
• Dependable with a high sense of responsibility.
• Efficient working style and hands-on entrepreneurial mentality.
• Able to fluently communicate in English and German, any additional languages are a plus.
• Be (financial) results-oriented for Hemex and its clients.
• Liaising as Regulatory Expert between the customer and internal staff.
• Team player who is able and willing to mentor other staff members.
• Interpersonal adaptability with a positive can-do attitude.
  

s.

Requirements

Regulatory Affairs Manager

The Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory requirements for pharmaceuticals, biologics, or biosimilars. Functional responsibilities will include:

• Definition and implementation of regulatory strategies for submissions in CH, EU, and /or the US in collaboration with other functional areas for pharmaceuticals.
• Lifecycle management and maintenance of documentation, and product approvals including MAA, CTAs, PIPs, Renewals, and Variations.
• Written, oral, and face-to-face interaction with Health Authorities in connection with product registrations (MAA / NDA), Clinical Trial Applications, Orphan drug designations, and Scientific advice including responding to health authority questions.
• Get involved hands-on with teams of innovative new healthcare solutions and consult and guide them through product development.
• Supervision of legal requirements and regulatory records to ensure proper traceability of regulatory history and of actual regulatory status.
• Solid working knowledge of regulations and guidelines governing drugs and biologics in development, specifically focused on EU, Swiss & US including clinical trials.
• Proactively identifies regulatory issues and offers creative solutions and strategies including risk mitigation strategies.
• Keep up-to-date with the requirements of the Medicines Authorities across the CH, EU, and rest of the world (where relevant).
• Pharmacovigilance experience preferred with Regulatory compliance in safety issues (SLCs, RMPs, DHPCs).
• Experience with CROs preferred.
• Where required, undertake departmental tasks and projects outside the area of responsibility in line with departmental and management team objectives.
  

Benefits

• Join a small team of multinational, multidisciplinary, highly motivated experts.
• Modern, inclusive, pleasant working environment in a fast-growing, dynamic organization.
• Ability to independently manage your role and responsibilities.
• Opportunity to develop yourself and support start-ups developing highly innovative therapies.
• We’re actively building diverse teams and specifically welcome applications people over the age of 50.
• Office-based employment in Liestal (Switzerland), 7min by foot from Liestal SBB train station.
  

If you meet the described profile, we look forward to receiving your CV in English, including supporting documents, by e-mail to