Regulatory Policy Specialist developing regulatory case filings and strategies supporting company goals at Xcel Energy. Collaborating with stakeholders and senior management to ensure compliance and effective communication.
About the role
- Regulatory CMC Manager supporting execution of global regulatory CMC tasks at Syneos Health. Collaborating with cross-functional teams to prepare submissions and maintain compliance in multiple locations.
Responsibilities
- Support the execution of multi-product global regulatory CMC for products at Marketing Authorisation Application Stage
- Contribute to the preparation and submission of regulatory CMC documentation
- Provide regulatory support to various cross-functional teams
- Participate in strategic Regulatory CMC discussions
Requirements
- Chemistry Manufacturing Controls experience
- Experience with regulatory submissions
- Knowledge of global regulatory CMC strategies
- Ability to work on cross-functional teams
- Strong verbal and written communication skills
Benefits
- We are passionate about developing our people, through career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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