Join Our Team
Elevatia Solutions is a Clinical research organization and consulting firm that provides support to drug, cosmetic & medical device companies:
- To conduct end to end clinical trials
- To partner with the medical affairs department and support in different activities.
- To provide regulatory affairs consultancy.
Through outstanding personnel, clear communications, and transparent operations. We are looking for dynamic professionals to join our team and help support our rapid growth and expanding services.
We are looking for new experienced and motivated individuals to join our team. Regardless of whether we currently have a position open to your specific expertise, feel free to contact us with your information along with a description describing how we could work together.
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We Are Hiring!
Join our team and be a part of an exciting and dynamic environment! We are currently looking for talented, motivated individuals to fill the following positions:
HR Manager
Job Description:
We are seeking a dynamic and experienced HR Manager to oversee all aspects of human resources practices and processes. The ideal candidate will be responsible for ensuring a high-performance culture, enhancing employee engagement, and implementing effective HR strategies that align with the organization’s goals.
Key Responsibilities:
- Develop and implement HR strategies and initiatives aligned with overall business objectives.
- Oversee the recruitment and selection process to attract, hire, and retain top talent.
- Manage the onboarding and training programs to enhance employee experience.
- Ensure compliance with labor laws and company policies.
- Develop and oversee performance management systems and employee evaluation programs.
- Handle employee relations, grievances, and disciplinary actions.
- Design and implement compensation and benefits programs.
- Foster a positive workplace culture and drive employee engagement initiatives.
- Maintain HR records and prepare reports for management.
- Develop and oversee HR policies and procedures.
Qualifications & Requirements:
- Bachelor’s/Master’s degree in Human Resources, Business Administration, or related field.
- Proven experience as an HR Manager or similar role.
- In-depth knowledge of labor law and HR best practices.
- Strong interpersonal and communication skills.
- Ability to work in a fast-paced environment and handle confidential information with integrity.
- Proficiency in HR software and Microsoft Office Suite.
If you are passionate about HR and people management, we would love to hear from you.
Clinical Trial Project Manager
Experience: 5+ years of experience in clinical trial management, with at least 2 years in a project management role.
Job Description:
The Clinical Trial Project Manager (CTPM) is responsible for overseeing and managing clinical trials from initiation to completion, ensuring compliance with regulatory requirements, timelines, and budgets. This role involves cross-functional coordination with internal and external stakeholders, including clinical research organizations (CROs), regulatory agencies, and study sites.
Key Responsibilities
Project Management & Oversight
- Plan, initiate, and execute clinical trials in accordance with regulatory guidelines (FDA, EMA, ICH-GCP).
- Develop and manage project timelines, budgets, and resources.
- Identify risks and develop mitigation strategies to ensure trial success.
- Oversee the selection, contracting, and performance of CROs, vendors, and study sites.
- Ensure timely and high-quality delivery of clinical trial milestones.
Regulatory Compliance & Quality Assurance
- Ensure trials comply with ICH-GCP, FDA, EMA, and other regulatory requirements.
- Oversee the preparation and submission of regulatory documents (IND, CTA, etc.).
- Conduct quality checks to ensure adherence to protocols and standard operating procedures (SOPs).
Stakeholder & Team Collaboration
- Work closely with cross-functional teams, including clinical operations, regulatory affairs, and data management.
- Serve as the primary point of contact for sponsors, investigators, and CROs.
- Provide leadership and mentorship to clinical research associates (CRAs) and study coordinators.
Data & Reporting
- Monitor trial progress and ensure timely data collection and reporting.
- Analyze and present trial findings to senior management and regulatory bodies.
- Ensure proper documentation and trial master file (TMF) maintenance.
Qualifications & Experience
- Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field (Master’s or Ph.D. preferred).
- Experience: 5+ years of experience in clinical trial management, with at least 2 years in a project management role.
Regulatory Affairs Manager
Experience: With 5+ years of experience in regulatory affairs within the pharmaceutical industry.
Job Description:
The Regulatory Manager is responsible for ensuring compliance with all regulatory requirements for pharmaceutical products. This role involves preparing and submitting regulatory documents, liaising with health authorities, and keeping up to date with changes in drug regulations. The manager works closely with internal teams, such as research and development (R&D), quality assurance (QA), and marketing, to ensure timely approval and maintenance of drug products.
Key Responsibilities:
- Regulatory Compliance & Strategy:
- Ensure compliance with local and international regulatory guidelines (e.g., FDA, EMA, MHRA, TGA, ICH).
- Develop regulatory strategies for new and existing products.
- Monitor and interpret regulatory changes and advise management on necessary actions.
- Regulatory Submissions & Documentation:
- Prepare, compile, and submit dossiers for drug approvals, renewals, and variations.
- Ensure timely submission of Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Marketing Authorization Application (MAA).
- Maintain and update regulatory documentation, including drug master files (DMFs) and common technical documents (CTDs).
- Liaison with Regulatory Authorities:
- Act as the primary contact for regulatory agencies.
- Address queries and provide necessary clarifications during the review process.
- Participate in regulatory meetings and audits.
Key Requirements:
- Education: Bachelor’s or Master’s degree in Pharmacy or related field.
- Experience: 5+ years of experience in regulatory affairs within the pharmaceutical industry.