Manager, Regulatory Affairs - CMC

Job Summary

This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies. He would be responsible for the preparation and review of information required for development of regulatory CMC dossiers for commercial products.

Primary responsibilities include, but are not limited to:

Regulatory Responsibilities

• Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
• Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements/variations, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
• Liaise with global CMC, Our Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Deliver all regulatory milestones for assigned products across the product lifecycle
• Identify and communicate potential regulatory issues to GRACS CMC management, as needed

Technical Skills

• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Proficient computer skills and previously demonstrated ability to operate in electronic document based GMP systems

Leadership Skills

• Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Demonstrated effective leadership, communication, and interpersonal skills

Qualifications Skills

• Bachelor's in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry
• Minimum 5 - 7 yrs of Industry Pharmaceutical industry experience out of 4 years experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics The candidate may be required to travel to other CMO sites on a need basis.

Required Skills

• Adaptability
• Business Decisions
• Change Controls
• Collaborative Leadership
• Compliance Investigations
• Documentation Review
• Documentation Standards
• Electronic Common Technical Document (eCTD)
• Employee Training Programs
• Global Coordination
• Global Regulatory Submissions
• Legal Compliance
• Life Cycle Planning
• Pharmaceutical Manufacturing
• Pharmaceutics
• Policy Implementation
• Records Retention Management
• Regulatory Affairs Management
• Regulatory CMC
• Regulatory Communications
• Regulatory Compliance
• Regulatory Documents
• Regulatory Management
• Regulatory Processes

Job Details

• Employee Status: Regular
• Relocation: Domestic
• VISA Sponsorship: No
• Travel Requirements: 50%
• Flexible Work Arrangements: Not Applicable
• Shift: Not Indicated
• Valid Driving License: Yes
• Hazardous Material(s): NA

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