Regulatory Affairs Manager - Marketed Products Development, GEM

Regulatory Affairs Manager - Marketed Products Development, GEM vacancy (requiring profound Pharma knowledge) for our Glattpark (Opfikon) based client in the Pharma sector.

Your tasks:

• Collaborates to define, develop and lead Marketed Products GEM strategies to maximize regulatory success towards achievement of program objectives
• Independently manages, plans and executes all aspects for the successful preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned program
• Effectively communicates the regulatory strategies, submission plans and timelines; and impact assessments of trends, regulations and changes related to assigned programs
• Stays current with regulations/guidances in Growth and Emerging Markets for impact on drug development plans, registration and life cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance
• Provides regulatory expertise on Marketed Products in GEM for multiple projects, focused on non-clinical and clinical aspects of registration and/or post-marketing compliance and life cycle management
• Assures ongoing efforts towards fulfilment of international product approval conditions for late stage programs
• Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams; company's consultants and Business Partners
• Evaluates new business development opportunities for Growth and Emerging Markets and/or participates on due diligence teams
• In coordination with local regulatory lead provides strategic guidance/advice on emerging trends, regulations and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs
• Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required. Interacts directly with HA, as required. Represents Takeda GEM RA in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps, as required
• Manages, trains, provides direction, strategic guidance and solutions to projects, mentors team members, to support scope of project work
• Partner with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans
• Responsible for demonstrating Takeda leadership behaviors

Your experience/knowledge:

• Bachelor's degree in a scientific discipline; BA accepted based on experience. Advance degree preferred.
• Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and/or post-marketing phases
• 4 years of directly related regulatory experience is desirable
• Solid regulatory experience, including knowledge of regulations and guidance governing drugs and biologics in development and life cycle management for growth and emerging markets; and US and EU (relevant to role), including interaction with Health Authorities
• Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies
• Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy
• Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
• Generally strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
• Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership
• Effective manager who is able to bring working teams together for common objectives
• Experience managing relationships with external vendors and/or contractors is also preferred

Your soft skills:

• Excellent comprehension skills with attention to detail
• A high degree of self-organization and time management
• Analytical and solution-orientated thinking

Location: Glattpark (Opfikon), Switzerland
Work setting:Hybrid
Sector:Pharma
Start:02/2025
Duration:6months +
Workload:100%
Ref.Nr.:BH 22609

Take the next step and send us your resume along with a daytime phone number where we can reach you.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are warmly welcomed, we will support you all the way.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.

As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.