Senior Regulatory Specialist managing regulatory activities for pharmaceutical CMC projects. Collaborating with diverse teams and ensuring timely delivery of regulatory documentation and compliance.
GS
Hybrid Senior Regulatory Specialist, Small Molecules, CMC, Global Regulatory Affairs
Posted 3 weeks ago
About the role
- Senior Regulatory Specialist managing regulatory activities across multiple CMC projects within Pharma business. Collaborating with diverse teams and mentoring new members to ensure 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), with 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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