Global CMC Regulatory Affairs Director

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 100,000 - 130,000; Full time

Benefits offered by this job

Excellent career progression opportunities

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

A global pharmaceutical company in Dublin is seeking a Director of Regulatory Affairs to develop strategic CMC regulatory approaches. The ideal candidate will have extensive CMC authoring experience, strong leadership skills, and in-depth knowledge of regulatory requirements. This role involves cultivating relationships with stakeholders, ensuring compliance with regulations, and managing cross-functional project teams. A competitive salary, bonus scheme, health insurance, and opportunities for professional growth are included.

Qualifications

• Extensive hands-on CMC authoring experience for regulatory submissions.
• Experience leading and managing technical teams and complex projects.
• In-depth knowledge of regulatory requirements across global markets.

Responsibilities

• Develop and implement CMC regulatory strategies for drug submissions.
• Establish relationships with regulatory agencies to ensure compliance.
• Lead cross-functional teams and manage resources and budgets.

Skills

CMC authoring experience

People and project management experience

Knowledge of cGMP

Regulatory negotiation skills

Education

Relevant degree in life sciences or related field

Job description

A global pharmaceutical company in Dublin is seeking a Director of Regulatory Affairs to develop strategic CMC regulatory approaches. The ideal candidate will have extensive CMC authoring experience, strong leadership skills, and in-depth knowledge of regulatory requirements. This role involves cultivating relationships with stakeholders, ensuring compliance with regulations, and managing cross-functional project teams. A competitive salary, bonus scheme, health insurance, and opportunities for professional growth are included.