Description :

1. Managed regulatory compliance projects, ensuring adherence to applicable regulations and standards.
2. Led cross-functional teams to ensure compliance with regulatory requirements and project timelines.
3. Developed and executed project plans, timelines, and budgets, ensuring timely completion.
4. Coordinated with internal teams to implement regulatory requirements and best practices.
5. Maintained comprehensive project documentation, including regulatory filings and audit reports.
6. Monitored project progress and communicated updates to stakeholders, ensuring transparency.
7. Assessed project risks and developed mitigation strategies to enhance project success.

Experience

0-2 Years

Level

Entry Level

Education

B.S. Regulatory Affairs

Description :

1. Conducted training sessions for team members on regulatory processes and requirements.
2. Assisted in developing and enhancing regulatory compliance programs, ensuring adherence to industry standards.
3. Prepared and submitted regulatory filings and reports to various regulatory agencies to ensure timely approvals.
4. Collaborated with cross-functional teams to address regulatory issues and implement corrective actions effectively.
5. Participated in regulatory audits and assessments to ensure compliance with audit findings and recommendations.
6. Maintained a comprehensive document inventory to support core dossier preparation and regulatory submissions.
7. Prioritized project-related tasks to ensure the efficient completion of essential regulatory processes.

Experience

2-5 Years

Level

Junior

Education

BSRA

Description :

1. Monitored regulatory changes impacting project objectives and activities to ensure compliance.
2. Created detailed project plans, defining scope, objectives, timelines, resources, and budgets.
3. Established clear project deliverables and success criteria aligned with regulatory requirements.
4. Collaborated with cross-functional teams, including Compliance, Legal, Quality Assurance, Operations, and Regulatory Affairs, to coordinate project activities.
5. Utilized project management tools to track progress and manage resources effectively.
6. Conducted comprehensive risk assessments and developed strategies to mitigate regulatory project risks.
7. Identified potential project risks, issues, and dependencies, proactively addressing them to ensure timely project completion.

Experience

5-7 Years

Level

Senior

Education

MSRA

Description :

1. Oversaw the execution of regulatory projects, ensuring alignment with compliance standards and organizational goals.
2. Led cross-functional teams in the development and implementation of regulatory strategies, enhancing project outcomes.
3. Monitored project progress, identifying variances and implementing corrective actions to maintain timelines and budgets.
4. Communicated project status, risks, and updates to stakeholders, ensuring transparency and alignment throughout the project lifecycle.
5. Maintained comprehensive project documentation, including regulatory filings, plans, and quality assurance reports.
6. Conducted audits and quality reviews, verifying compliance with regulatory requirements and project specifications.
7. Prepared and submitted regulatory reports and disclosures, adhering to all regulatory standards and guidelines.

Experience

7-10 Years

Level

Management

Education

MSRA

Description :

1. Evaluated project performance and implemented best practices to enhance regulatory compliance and team effectiveness.
2. Conducted comprehensive analyses to identify regulatory risks and provided actionable recommendations.
3. Simplified implementation processes while ensuring adherence to compliance standards.
4. Identified optimal solutions to mitigate unintended regulatory impacts while maintaining compliance.
5. Ensured timely project deliveries within budget, aligned with regulatory and internal requirements.
6. Facilitated change management training and documentation for affected teams to enhance compliance readiness.
7. Monitored quality assurance for submissions, ensuring adherence to regulatory guidelines and timelines.

Experience

10+ Years

Level

Executive

Education

MSRA

Description :

1. Designed and executed regulatory strategies to foster a culture of compliance and ethics across projects.
2. Collaborated with cross-functional teams to drive project success and ensure regulatory alignment.
3. Utilized project management software to track progress and manage documentation effectively.
4. Oversaw the delivery of major regulatory projects, ensuring timely completion and adherence to standards.
5. Monitored compliance with government regulations and provided guidance to teams on best practices.
6. Assisted in the development of operational models and system requests to support regulatory initiatives.
7. Engaged with stakeholders to align project objectives with regulatory requirements.

Experience

2-5 Years

Level

Executive

Education

B.S. Reg. Affairs

Description :

1. Prepared presentations for senior management on regulatory project status.
2. Assisted in the development of multicountry regulatory strategies, adapting as regulatory landscapes evolved.
3. Managed multiple work streams in complex regulatory projects, ensuring timely delivery and compliance.
4. Collaborated with Regulatory Affairs officers and compliance managers to streamline internal processes.
5. Supported the growth of new business initiatives by providing regulatory expertise to clients.
6. Partnered with IT and operational teams to improve regulatory service delivery.
7. Contributed to the formulation and execution of the business strategy for regulatory initiatives.

Experience

0-2 Years

Level

Fresher

Education

B.S. in RA

Description :

1. Directed the planning and execution of regulatory initiatives, ensuring alignment with organizational goals.
2. Oversaw the management of systems and processes for multiple global change programs.
3. Maintained proactive communication with stakeholders on all aspects of implementation.
4. Acted as a subject matter expert on regulatory frameworks and compliance requirements.
5. Utilized local and Head Office reporting tools to monitor project execution and progress.
6. Provided regular updates to the Head Office Steering Committee on project status and milestones.
7. Supported the Hambros PMO in developing and implementing best practice tools and templates for project management.

Experience

5-7 Years

Level

Senior

Education

MBA

Description :

1. Evaluated third-party vendors for regulatory services, selecting partners that aligned with company objectives while maximizing ROI.
2. Devised robust contingency plans to address potential delays in regulatory submissions, ensuring project continuity.
3. Managed application processes and regulatory inquiries, tracking progress and ensuring compliance with industry standards.
4. Optimized resource allocation for regulatory projects, effectively managing timelines and budget constraints.
5. Achieved timely regulatory approvals by coordinating cross-functional teams and aligning with industry guidelines.
6. Implemented standardized procedures for managing regulatory documents, enhancing organizational efficiency and compliance.
7. Developed strategies to secure the earliest possible approvals for products, improving market readiness.

Experience

7-10 Years

Level

Management

Education

MSRA

Description :

1. Facilitated cross-departmental collaboration by establishing structured communication channels and regular reporting, enhancing regulatory project efficiency.
2. Monitored and analyzed changes in regional regulations, ensuring timely dissemination of information to maintain organizational compliance.
3. Conducted comprehensive gap analyses on regulatory documentation, identifying and implementing improvements to align with current guidelines.
4. Mentored and coached junior team members, fostering a culture of professional growth and regulatory expertise within the team.
5. Executed quality control checks on regulatory submissions, ensuring adherence to company standards and compliance requirements.
6. Reviewed field study reports, synthesizing key information and producing concise summaries for regulatory submissions.
7. Engaged with regulatory agencies to clarify product-related inquiries, maintaining positive relationships and facilitating smooth communication.

Experience

10+ Years

Level

Executive

Education

M.S. in RA