Team Lead Regulatory CMC Writing (m/f/d)

Merz Therapeutics; Frankfurt; Hybrid; EUR 75.000 - 95.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Frankfurt is seeking a Team Lead Regulatory CMC Writing (m/f/d) to coordinate regulatory documentation for their manufacturing site. The ideal candidate will have 3-5 years of regulatory affairs experience in the pharmaceutical sector and strong communication skills. This role offers a hybrid work model and attractive benefits, all aimed at improving patient outcomes.

Leistungen

Individual career development

Hybrid work model

Company restaurant

Attractive remuneration with social benefits

Employer-subsidized benefits

Qualifikationen

• 3-5 years of professional experience in regulatory affairs within the pharmaceutical industry.
• Experience in technical writing of regulatory documentation.
• Knowledge of global CMC regulations and best practices.

Aufgaben

• Prepare CMC documentation in compliance with internal requirements.
• Supervise and coach a Regulatory CMC Writing Manager.
• Review draft documentation with the CMC RA and respective site.
• Conduct initial impact assessments on documentation changes.
• Support GMP inspections as needed.

Kenntnisse

Regulatory affairs expertise

Technical writing of module 3

Strong communication skills

Problem-solving abilities

Analytical thinking

Team player mentality

Business fluent in English

Ausbildung

Completed scientific studies in Pharmacy, Biology, Chemistry or related field

Doctorate is an advantage

Jobbeschreibung

YOUR CONTRIBUTION

As a Team Lead Regulatory CMC Writing(m/f/d), you will be the central contact point for our manufacturing site for development and maintenance of regulatory documentation to support creation of actual regulatory dossiers. This will include the following activities:

• Preparation of CMC documentation in compliance with internal requirements and in collaboration with the manufacturing organization
  
• Supervise a Regulatory CMC Writing Manager including coaching, performance review, ensuring compliance, and monitoring performance and its improvement
• Review draft documentation with the CMC RA and the respective site
• Conduct initial impact assessments, ensures justified documentation of changes
• Provide documentation per LoQ scope and timeline, and coordinates related tasks with the manufacturing site
• Define and coordinate required information and documentation with the manufacturing site and contractors to meet agreed regulatory timelines
• Support GMP inspections as needed
• Keep current on global CMC regulations and best practices

YOUR PROFILE

• Completed scientific Studies in Pharmacy, Biology, Chemistry or a related field of studies, a doctorate is an advantage
• 3-5 years of professional experience dealing with regulatory affairs aspects within the pharmaceutical industry, especially with technical writing of module 3
• Strong communication and problem-solving skills and analytical thinking ability
• Team Player with performance orientation and persistence
• Solution-oriented with a focus on compliance and quality
• Business fluent in English, German is an advantage

YOUR BENEFITS

• Individual career development in a purposeful job: you improve the quality of life of our patients!
• Hybrid work model that allows a good work-life balance
• Attractive location with good transport links, modern workplaces and a company restaurant
• Global family business with flat hierarchies and an open, respectful corporate culture
• Attractive remuneration with extensive social benefits
• Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike

ABOUT US

Welcome to Merz Therapeutics,a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases and other health conditions regain their quality of life.

We are proudto be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.

Our goalis to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.

Our dedication and commitmentto relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.

Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal: "BETTER OUTCOMES FOR MORE PATIENTS"

For more information, visithttps://www.merztherapeutics.com/.