Regulatory CMC Manager Bucharest

Regulatory CMC Manager
Bucureşti
Bucharest, Bucharest, Romania

TFS Health
Science is a leading global
- size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring
- saving treatments to patients worldwide.

Sponsor: You will be dedicated to a global pharmaceutical/biotech leader in innovative drug development, helping to bring
- changing therapies to market.

Role Overview

As a Regulatory CMC Manager, you will play a pivotal role in overseeing and coordinating Regulatory CMC (Chemistry, Manufacturing, and Controls) activities to support tech transfer projects. You will work closely with production sites, regulatory authorities, and internal teams to ensure regulatory compliance across multiple countries and facilitate seamless project execution.

Key Responsibilities

Develop and Implement Global CMC Strategies

• Design and execute comprehensive regulatory strategies to meet diverse global requirements across production sites.

Manage Regulatory CMC Activities

• Oversee the preparation, submission, and management of CMC documentation for regulatory filings.

Coordinate Change Notifications

• Manage change notifications to ensure timely and accurate regulatory updates across global markets.

Stakeholder Collaboration

• Build and maintain strong relationships with internal and external stakeholders, including regulatory agencies, supply chain teams, and manufacturing sites.

Support Tech Transfers

• Align Regulatory CMC activities with tech transfer processes, ensuring smooth transitions while maintaining compliance.

Qualifications

• Proven expertise in Regulatory CMC in a global environment, including regions such as Asia, LATAM, USA, and EU.
• Strong understanding of CMC regulatory requirements for pharmaceuticals, particularly solid dosage forms.
• Experience managing regulatory submissions and handling change control processes.
• Excellent communication and organizational skills to facilitate collaboration across
  - functional teams.
• Ability to manage complex projects and adapt plans to address unforeseen challenges.

What We Offer

• Competitive compensation for your expertise and contributions.
• Opportunity to lead high-impact global projects in a collaborative environment.
• Flexibility to work remotely, offering a healthy
  - life balance.
• A chance to work with a global organization committed to innovation and
  - focused solutions.

Join Us

At TFS Health
Science, we believe in creating solutions that matter, driven by shared values and a commitment to a healthier future. Join our team and be part of a company that values excellence, innovation, and collaboration, as we work together to bring new treatments to patients worldwide.