Openings at Signant Health

• The Project Specialist handles daily project assigned tasks and correspondence with internal stakeholders. This role supports Associate Project Managers (APM) and Project Managers with internal and external project meetings, creating, reviewing, and updating project documentation, systems, status reports and other material as needed.

As part of our team, your main responsibilities will be:

• Supports efforts associated with successful execution of all project tasks as directed by the project APM and/or Project Manager.
• Ownership of discrete, delegated project tasks during the project lifecycle.
• Maintenance of detailed project documentation including meeting minutes, action items, issues lists and risk management plans.
• Escalate project escalations as appropriate in a timely manner and assist in resolution with internal stakeholders.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

Decision making and influence:

• Responsible for compliance with Company Procedures in support of client deliverables.
• Recognize, exemplify and adherence to the company values which center around our commitment to people, clients, and performance.

You’ll need to bring: 

Essential:

• Must be able to use own initiative and work independently as needed.
• Must be a team-oriented person with a “can do” attitude.
• Must be able to communicate effectively with all members of Project Management and have excellent written and spoken English skills.
• Able to multi-task and work with multiple team members.
• Must have excellent time management and organizational skills.
• Must be detail orientated.
• Must have solid MS Office Suite experience – Word, Excel, PowerPoint.

Desirable:

• Bachelors’ degree or equivalent or relevant experience.
• Background in Pharmaceutical, Medical education and/or CRO.
• Experience of clinical trials/pharmaceutical industry/life sciences.

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• The Senior Technology Regulatory Compliance Analyst is responsible for ensuring compliance with global regulatory standards across Signant Health’s technology functions, including Enterprise IT, Cloud Operations, and R&D. Based in South Africa, this role provides leadership and expertise in regulatory compliance, focusing on systems and processes that support internally developed software products sold within the life sciences industry and Enterprise IT solutions. Reporting to the Associate Director of Regulatory Compliance, this position collaborates with cross-functional teams to build and maintain robust compliance frameworks.

Key Responsibilities:

Regulatory Compliance Oversight:

• Lead compliance efforts for technology functions to ensure adherence to global regulatory standards, including FDA 21 CFR Part 11, GAMP 5, ICH GCP, and EMA guidelines.
• Develop, implement, and maintain compliance frameworks for Enterprise IT, Cloud Operations, and R&D.
• Provide expert advice on regulatory requirements during the development and deployment of software products.
• Ensure software products meet global regulatory requirements applicable to the life sciences industry.

Audit and Risk Management:

• Plan and lead internal audits of IT systems and processes to assess compliance readiness.
• Support external audits and inspections by regulatory authorities and customers.
• Conduct risk assessments, identify potential compliance gaps, and oversee the implementation of mitigation strategies.

Policy and Documentation Management:

• Develop, review, and update policies, SOPs, and other documentation to align with regulatory requirements.
• Ensure validation and verification processes for IT systems and software are adequately documented and maintained.

Collaboration and Cross-Functional Engagement:

• Collaborate with Enterprise IT, Cloud Operations, and R&D teams to embed compliance into system design, software development, and operations.
• Act as a liaison with external stakeholders, including auditors and regulatory bodies, to address compliance-related queries.

Training and Mentorship:

• Design and deliver training programs on regulatory compliance requirements for technology teams in India.
• Mentor and guide junior analysts to ensure consistent application of compliance principles.

Continuous Improvement:

• Drive continuous improvement initiatives to enhance compliance processes and frameworks across technology functions.
• Stay updated on emerging trends and regulatory changes impacting the life sciences and software development industries.

Qualifications:

Education:

• Bachelor’s degree in Information Technology, Computer Science, Regulatory Affairs, or a related field.
• Advanced degree or certifications (e.g., RAC, CRCP, or equivalent) preferred.

Experience:

• 5-10 years of experience in IT regulatory compliance, particularly in life sciences or software development.
• Strong experience with global regulatory frameworks, including FDA 21 CFR Part 11, GAMP 5, and ICH GCP.

Skills and Competencies:

• Comprehensive understanding of IT systems, cloud operations, and software development lifecycle (SDLC).
• Proven ability to manage audits and regulatory inspections with strong problem-solving skills.
• Excellent project management, communication, and leadership abilities.
• Experience in working with geographically dispersed teams and global stakeholders.

Preferred Qualifications:

• Familiarity with Agile and DevOps methodologies.
• Experience with compliance in cloud-based environments and data security standards.