Part - time Proposal Writer crafting persuasive proposals for engineering and environmental contracts with government agencies. Collaborating with experts to secure new contracts while working remotely from Maryland.
About the role
- Team Lead Regulatory CMC Writing developing regulatory documents in collaboration with manufacturing site at Merz Therapeutics. Leading a team for compliance with regulatory requirements and documentation.
Responsibilities
- Primary contact for our manufacturing site for the development and maintenance of regulatory documents to support the preparation of current regulatory dossiers.
- Preparation of CMC documentation in accordance with internal requirements and in collaboration with the manufacturing organization.
- Supervision of a Regulatory CMC Writing Manager, including coaching, performance evaluation, ensuring compliance, and monitoring and improving performance.
- Review of draft documentation with the CMC Regulatory Affairs (CMC RA) team and the respective site.
- Conduct initial impact assessments and ensure changes are documented with clear justification.
- Deliver documentation according to LoQ scope and schedule, and coordinate associated tasks with the manufacturing site.
- Define and coordinate required information and documents with the manufacturing site and contractors to meet agreed regulatory deadlines.
- Provide support for GMP inspections as needed.
- Stay up to date with global CMC regulations and best practices.
Requirements
- University degree in pharmacy, biology, chemistry, or a related scientific discipline; a PhD is an advantage.
- 3–5 years of professional experience in regulatory affairs within the pharmaceutical industry, particularly with technical documentation for Module 3.
- Strong communication and problem-solving skills, with analytical thinking.
- Team player with a performance orientation and resilience.
- Solution-focused with a strong emphasis on compliance and quality.
- Business-fluent English; German is an advantage.
Benefits
- Individual career development in a meaningful role: you improve the quality of life for our patients!
- Hybrid working model that enables a good work–life balance.
- Attractive location with good transport connections, modern workspaces, and a company canteen.
- Global family-owned company with flat hierarchies and an open, respectful corporate culture.
- Competitive compensation with comprehensive social benefits.
- Variety of employer-funded benefits such as WellPass, the Deutschland-Ticket, Corporate Benefits, and JobBike.
Job title
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Experience level
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