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GS
Hybrid Senior Regulatory Specialist, Small Molecules, CMC, Global Regulatory Affairs
Posted 3 days ago
About the role
- Senior Regulatory Specialist managing regulatory activities for pharmaceutical CMC projects. Collaborating with diverse teams and ensuring timely delivery of regulatory documentation and compliance.
Responsibilities
- Ensuring timely and efficient delivery of regulatory activities across multiple CMC projects within Pharma business.
- Preparing technical documentation for global regulatory changes.
- Responding to Regulatory Agency inquiries.
- Providing expert guidance on CMC variations for Active Pharmaceutical Ingredients (APIs), Intermediates, and Drug Products.
- Collaborating with diverse teams across Global Regulatory Organization, Global Supply Chain, Quality Assurance, and Contract Manufacturing Organizations.
- Mentoring and training new team members.
Requirements
- Bachelor’s or Master’s degree in biotechnology, chemical technology, pharmacy, chemistry, or another related science or technical field.
- Relevant experience in regulatory affairs (the pharmaceutical industry).
- Familiarity in post-approval CMC regulatory procedures and ICH CTD documentation (Modules 2 and 3).
- Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
- Thorough understanding of change management processes and regulatory requirements.
- Attention to detail with an emphasis on accuracy and completeness.
- Ability to handle multiple tasks, meet shifting priorities, and schedule work to meet business needs.
- Flexible and analytical thinking to independently provide solutions to issues.
- Excellent interpersonal skills, including the ability to communicate clearly and effectively, work in a diverse team environment, and build relationships across a large organization.
- Excellent written and verbal communication skills in English.
Benefits
- Medical Plan
- Life Insurance
- Employee Retirement Program
- Sport and recreation cards
- Recreation allowance
- Annual bonus
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