
Regulatory Compliance Professional
1 day ago
We're seeking an experienced Regulatory Compliance Manager to join our team. The ideal candidate will have a strong background in Quality and Compliance managed services, with experience in Computer System Validation and Stakeholder Management.
This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offerings. As a Regulatory Compliance Manager, you will help clients understand their business needs and deliver solutions in accordance with professional standards and guidelines.
Key Responsibilities:- Actively contribute to IT applications project management initiatives that include Validation activities as per GAMP Life Cycle approach
- Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
- Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies are in line with Life Cycle Approach
- Perform Software classification, IT risk assessment and Mitigation strategies for IT applications.
- Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with clients to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
- Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
- Identify opportunities in existing accounts to cross-sell other services.
- Planning and monitoring of the project deliverables from the team.
- Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.
- Demonstrate teamwork by working with cross-functional teams across service lines in completing the deliverables within the timelines
- Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
- Regular status reporting to the Senior Managers, Partners, Directors and onsite coordinators.
- Actively contribute to improving operational efficiency on projects & internal initiatives.
- Demonstrate a detailed knowledge of market trends, competitor activities, products and service lines.
- Bachelor of Engineering or Technology (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 10-12 years of experience with Big 4 or Multi-National Regulatory Compliance companies
- Good interpersonal skills; Good written and presentational skills
- At managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations
- Experience in managing team and solution designing
This role offers a unique opportunity to work with a talented team, drive business growth, and develop your career in a dynamic and supportive environment.
We offer a competitive compensation package, including a base salary, bonus structure, and benefits program.
Others:We are an equal opportunities employer and welcome applications from diverse candidates.
Please submit your application, including your resume and cover letter, through our website.
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