Lead Consultant - Regulatory Affairs

Responsibilities

The Role demands for a highly qualified professional who should have CMC experience under regulatory affairs domain. BA will be responsible for all the activities related to

Provide input to 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, annual reports, registration renewals and responses to health authority questions per established business processes and systems.

Collaborate closely with MMD and partners to support compliant execution of organizational change and conduct all activities with an unwavering focus on regulatory conformance.

Assess and communicate potential regulatory risks and propose mitigation strategies.

Deliver all regulatory results for assigned products across the product lifecycle

Identify and communicate potential regulatory issues to GRACS CMC, as needed

Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).

Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key partners.

Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.

Capability to handle multiple priorities and balance work to achieve business goals.

Minimum Qualifications

Bachelor's degree in pharma / Science

Strong financial analytical skills and problem solving skills.

Effective communicate in writing and verbally to senior management.

Experience in balancing customer facing role and work assessments.

Self-starter and have analytical, prioritization skills

Ability to balance customer governance meetings

Preferred qualifications

Able to further robust working relationships with the team, peers and clients, scheduling flexibility required

Overall candidate should have decision-making, macro-level research and analytics approach and good in numbers.

Good people and customer handling skills.

Effective communication and interpersonal skill.