CMC Regulatory Scientist I

Job Description

Job Summary:

• The Senior Specialist is responsible for developing CClient regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance.
• The Senior Specialist is also responsible for the preparation and review of information required for development of regulatory CClient dossiers for new and existing commercial products.

Duties and Responsibilities:

• Work independently and effectively with other functions to manage and prepare regulatory CClient dossiers, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country to product new and maintain existing product registrations.
• Assess post approval changes, provide regulatory filing strategies and timelines, identify risks and propose mitigation strategies.
• Ensure important submissions/tasks are completed on a timely basis.
• Actively participate on new product development teams as well as other types of teams and initiatives and deliver on all assigned regulatory milestones.
• Maintain regulatory information in accordance with processes and procedures to support regulatory compliance.
• Continuously build and share knowledge of CClient related regulations and guidelines (including but not limited to FDA-CVM, EMA, and VICH), authority expectations, as well as current industry standards.
• Identify and communicate potential regulatory issues to management, as needed.
• Perform other tasks as requested by management.

Education and Experience:

• Bachelor of Science degree (minimum) in science, engineering, or other relevant field (advanced degree preferred).
• At least 2 years of relevant experience (for example: pharmaceutical research, manufacturing, or quality).
  Proficient in English and high level of professionalism.
• Experience reviewing scientific information.

Knowledge, Skills, and Abilities:

• Demonstrated oral and written communication skills.
• Demonstrated understanding of related fields (manufacturing, testing, and quality assurance).
• Leadership skills including problem solving, ability to deal with multiple priorities, strong interpersonal skills, sound judgement, and attention to detail.
• Previous CClient experience is preferred.