Regulatory Affairs Consultant

Our client, a global leader in the pharmaceutical industry known for their progressive pipeline of small molecule products, is seeking an experienced Regulatory Affairs Consultant. This role is crucial for driving their post-marketing strategy, including CMC, variations, and full life cycle management.

For this position we are seeking someone that does not shy away from being hands on while work antonymous. This is a global position; as such, experience managing strategy in ROW, Emerging markets, EMA, FDA will be highly advantageous.

While this position is temporary we can also review those who are seeking a permanent position with the ability to start in 1-2 months.

Key Responsibilities:

• Develop and implement regulatory strategies for post-marketing activities.
• Manage CMC (Chemistry, Manufacturing, and Controls) documentation and ensure compliance with regulatory requirements.
• Handle variations and life cycle management for marketed products.
• Liaise with global regulatory authorities and provide strategic advice to internal teams.
• Ensure all regulatory submissions meet local and international standards.

Requirements:

• Proven experience in regulatory affairs within the pharmaceutical industry.
• Strong knowledge of post-marketing regulatory requirements.
• Expertise in CMC documentation and variations management.
• Excellent communication and interpersonal skills.
• Ability to travel occasionally to Basel or Western regions of Switzerland.
• Fluency in English and French.

If you are a dedicated and experienced Regulatory Affairs professional looking for an exciting new challenge, we would love to hear from you. Please apply with your CV and a cover letter detailing your relevant experience.