Regulatory Affairs Manager CMC

Planet Pharma; Uxbridge; On-site; GBP 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Manager CMC to join their team on an initial 6-month contract. This role involves developing regulatory strategies, managing CMC submissions, and collaborating with affiliate offices to ensure compliance with global regulations. The ideal candidate will have over 5 years of experience in regulatory affairs, particularly within the biopharmaceutical sector. This opportunity offers a chance to work in a dynamic environment that values compliance and innovation, making a significant impact in the regulatory landscape of the industry. If you are passionate about regulatory affairs and looking to advance your career, this role could be the perfect fit for you.

Qualifications

• 5+ years of experience in regulatory affairs with a focus on CMC.
• Strong understanding of global and local regulatory requirements.

Responsibilities

• Develop country-specific regulatory strategies for multiple products.
• Manage regulatory CMC submissions in compliance with regulations.

Skills

Regulatory Affairs

Regulatory Intelligence

Change Control

CMC Submissions

Education

Degree in a relevant field

Job description

Direct message the job poster from Planet Pharma

Planet Pharma are partnered with a global biopharmaceutical company who are now seeking a Regulatory Affairs Manager CMC on an initial 6 month contract with potential of extension.

Key Responsibilities:

• Develops country-specific regulatory strategies and provides feedback on submission plans for multiple products.
• Collaborates with affiliate offices on strategies and activities impacting specific countries.
• Addresses CMC regional issues and ensures appropriate contingency plans for global regulatory filings.
• Manages regulatory CMC submissions (e.g., clinical trials, variations, marketing applications) in compliance with global and local requirements.
• Gathers regulatory intelligence, provides guidance on change control requests, and keeps stakeholders updated on regional considerations and new regulations.

Key Requirements:

• Degree in a relevant field
• 5+ years experience in a relevant role

About Planet Pharma:

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

Please click ‘apply’ or contact Harry Banks (Recruiter II) at Planet Pharma for more information:

E: [e-mail]

T: [phone]

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Science and Research
• Industries: Pharmaceutical Manufacturing and Biotechnology Research