Job Description

I\xe2\x80\x99m currently seeking a highly motivated and experienced Regulatory Affairs Manager to join our team for an initial 6-month contract.

As the Regulatory Affairs Manager, you will play a pivotal role in ensuring compliance with regulatory requirements and contributing to our product portfolio\xe2\x80\x99s regulatory strategy across your given region (JAPAC)

Responsibilities:

• Develop country-specific regulatory strategies and provide internal teams with submission plans and execution feedback for one or more products.
• Collaborate with affiliate offices on strategies affecting specific countries.
• Address regional CMC issues, identify risks, and plan contingencies for global CMC filings.
• Review M2 and M3 CMC components for submission suitability in relevant countries.
• Manage regulatory CMC submissions, including clinical trials, variations, extensions, and marketing applications, in line with global and local regulations.
• Author and coordinate responses to regulatory queries for assigned products and regions.
• Define regional supply chain needs for reliability and successful launches in collaboration with regional stakeholders.
• Provide guidance for regulatory change control assessments.
• Set project timelines and priorities for assigned products based on objectives and resource constraints.
• Gather and analyse regulatory intelligence for International Markets and apply it to product-specific activities.
• Share regulatory information and implications with stakeholders and offer regional advice.
• Stay informed about new legislation, regulatory policy, and technical guidance related to company products.
• Conduct regulatory research to gather relevant historical data for regional product advancement.

Requirements:

• Bachelor\xe2\x80\x99s degree in a relevant field; advanced degree preferred.
• Substantial regulatory affairs experience in the pharmaceutical or biotechnology industry (Minimum 5 years)
• Strong knowledge of regulatory requirements within the APAC region
• Excellent communication and interpersonal skills.
• Demonstrated ability to manage complex regulatory submissions.
• Excellent knowledge of CMC regulatory requirements.
• Attention to detail and a proactive work style.

If you or a friend are looking for a new and refreshing role or have any questions about the position, then give me a call, drop me a message, or apply directly below and get ahead of the crowd! I look forward to hearing from you.

For a confidential discussion about this role, or to apply, then send your CV to c.buckley@nonstop-recruitment.com or call me, Corey Buckley, Recruitment Consultant \xe2\x80\x93 Life Sciences \xe2\x80\x93 Switzerland, at +41 435 080 817 (intern 3117). Please feel free to visit my LinkedIn profile to see my references/recommendations.

NonStop is one of the largest and fastest-growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across

NonStop Consulting