Role and Responsibilities: Reporting to the CMC-3 resource, the CMC-1 is responsible for executing CMC regulatory strategies for assigned products in accordance with global regulations, guidance and defined regulatory strategies to include but not limited to activities identified in Sections 1, 2 and 3 above.
Typical Accountabilities:

• Provide input to project 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, and responses to health authority questions per established business processes and systems.

• Liaise with Client 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, 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

Experience: At least three (3) years of relevant CMC pre/post approval experience, which may include research; manufacturing, testing, or licensure of products; or related fields.
Education Requirements: Bachelor's degree required in science, engineering or related field (advanced degree preferred). The candidate must be proficient in English, additional language skills are a plus.
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 and the ability to execute tasks independently.

Syner-G is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Syner-G is an E-Verify employer.

Job Type: Full-time

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