Environmental Engineer at Geosyntec managing compliance projects and mentoring professionals. Overseeing environmental audits and ensuring regulatory compliance in engineering consulting.
About the role
- Regulatory Responsible leading CMC activities at Opella, ensuring compliance and supporting Marketing Authorizations. Involves documentation, change control, and collaboration with regulatory affairs.
Responsibilities
- Manage CMC documentation: Write, update, and review regulatory CMC dossiers for submission; coordinate internal and external CMC writing; optimize dossier content for future changes; prepare responses to Health Authority queries.
- Support Marketing Authorizations worldwide: Handle territory extensions, renewals, site registrations, and transfers by preparing CMC documents and collecting GMP-related documentation.
- Change Control: Assess regulatory impact of product lifecycle changes; define regulatory strategies; track submissions and approvals of variations globally.
- Ensure Regulatory Compliance: Align CMC dossiers with manufacturing and control procedures; evaluate compliance against current regulations; define corrective actions for gaps.
- Act as the regulatory interface with Global and Affiliate Regulatory Affairs for EM CHC.
- Support business units in managing new opportunities and product launches.
Requirements
- Hands-on experience in CMC writing and/or Regulatory Affairs.
- Background in pharmaceutical industry within GMP environments (Quality Assurance, Development, Production, or Quality Control).
- Strong written and verbal communication skills; ability to collaborate across functions.
- Excellent organizational skills with attention to detail and ability to manage multiple priorities.
- Knowledge of global drug regulations (EU, FDA, ICH, China).
- Familiarity with Veeva Vault RIM and Veeva Vault Quality is a plus.
- Proficient in English (written and spoken); additional languages are a plus.
Benefits
- Health insurance
- Competitive salary
- Professional development opportunities
- Flexible work arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Junior Consultant supporting security and compliance projects for SMEs in Germany. Collaborating on NIS2, ISO 27001, and TISAX with structured guidance and clear responsibilities.
Senior regulatory reporting specialist for investment bank, building MiFID II and EMIR reporting functions from ground up with senior stakeholders.
Director of Regulatory Affairs leading engagement in ERCOT and SPP wholesale markets. Managing regulatory strategies and influencing outcomes on market design and policy issues.
Senior Director providing strategic leadership for U.S. wholesale electricity markets. Managing teams and regulatory strategy to enhance utility - scale project development.
Apprentice Regulatory Compliance Officer supporting compliance for Yara's product registrations. Collaborating with internal teams and ensuring adherence to regulatory standards in the UK.
Regulatory Affairs Officer ensuring compliance for Yara's agricultural products. Supporting global product registrations and liaising with regulatory teams and suppliers.
Risk & Compliance Officer assisting in risk management and compliance within Arthur Cox LLP. Engaging with legal and business support to uphold regulatory standards and protect firm’s reputation.
Vice President leading Government, Regulatory and Public Affairs at Modivcare. Overseeing advocacy, lobbying, and strategic engagement with public policy stakeholders.
Compliance Advisor for Global Sanctions supporting Fidelity’s enterprise Global Sanctions program. Responsibilities include alert management, investigations, and technology support.