Careers

We are seeking a Regulatory Affairs Specialist with experience in handling submissions and compliance for European and US markets. The role involves managing regulatory activities, ensuring adherence to global guidelines, and supporting product registrations and lifecycle management.

1. Key Responsibilities:
   • Prepare, review, and submit regulatory dossiers for US (FDA) and Europe (EMA) markets.
   • Handle submissions such as ANDA, NDA, MAA, variations, renewals, and
   amendments.
   • Ensure compliance with regional regulatory requirements and guidelines.
   • Coordinate with cross-functional teams (R&D, QA, Manufacturing) for regulatory inputs.
   • Manage product lifecycle activities including post-approval changes.
   • Review labeling documents to ensure alignment with regulatory requirements.
   • Track submission status and respond to regulatory queries/deficiencies.
   • Maintain regulatory documentation and databases.
    
2. Required Skills & Qualifications:
   • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
   • 3–8 years of experience in Regulatory Affairs for US and/or EU markets.
   • Strong knowledge of FDA and EMA guidelines and submission processes.
   • Experience in eCTD submissions and regulatory tools.
   • Good understanding of CMC, labeling, and dossier compilation.
   • Strong communication and coordination skills.


3. Preferred Skills:
   • Experience with global submissions (ROW markets is a plus).
   • Familiarity with regulatory publishing tools and document management systems.
   • Ability to manage multiple projects and deadlines.
   

We are seeking a Regulatory Affairs Specialist with experience in cosmetic product registration and compliance across UAE and GCC markets. The role involves managing regulatory submissions, ensuring compliance with local authorities, and supporting product approvals and lifecycle management.

1. Key Responsibilities:
   • Prepare, review, and submit cosmetic product registration dossiers for UAE and GCC markets.
   • Handle product registrations through portals such as Montaji (UAE) and other GCC regulatory systems.
   • Ensure compliance with UAE Municipality, SFDA (Saudi Arabia), and other GCC regulatory requirements.
   • Review product formulations, labels, and claims as per GCC cosmetic regulations.
   • Coordinate with cross-functional teams (R&D, QA, Marketing) for required documentation.
   • Manage product lifecycle activities including renewals, variations, and amendments.
   • Track submission status and respond to authority queries.
   • Maintain regulatory documentation and compliance records.
    
2. Required Skills & Qualifications:
   • Bachelor’s or Master’s degree in Pharmacy, Chemistry, Life Sciences, or related field.
   • 2–6 years of experience in cosmetic regulatory affairs for UAE/GCC markets.
   • Strong knowledge of UAE and GCC cosmetic regulations and guidelines.
   • Experience with Montaji portal and other GCC registration systems.
   • Good understanding of cosmetic formulations, labeling, and claims compliance.
   • Strong attention to detail and communication skills.
    
3. Preferred Skills:
   • Experience with SFDA (Saudi Arabia), Kuwait, Oman, Qatar, and Bahrain regulations.
   • Familiarity with GCC Standardization Organization (GSO) guidelines.
   • Ability to manage multiple product registrations and timelines.

We are seeking a Regulatory Affairs Specialist with experience in US 510(k) submissions and European medical device regulations. The role involves managing regulatory submissions, ensuring compliance with FDA and EU MDR requirements, and supporting product approvals and lifecycle management.

1. Key Responsibilities:
   • Prepare, review, and submit 510(k) dossiers for the US market.
   • Support CE marking activities in compliance with EU MDR (2017/745) requirements.
   • Compile and maintain technical documentation, including Technical Files/Design Dossiers.
   • Ensure compliance with FDA and EU regulatory guidelines for medical devices.
   • Coordinate with cross-functional teams (R&D, QA/RA, Clinical, Manufacturing) for regulatory inputs.
   • Manage product lifecycle activities including changes, renewals, and post-market updates.
   • Review labeling, IFUs, and promotional materials for regulatory compliance.
   • Respond to regulatory authority queries, deficiencies, and audit observations.
   • Maintain regulatory documentation and submission tracking systems.
    
2. Required Skills & Qualifications:
   • Bachelor’s or Master’s degree in Biomedical Engineering, Pharmacy, Life Sciences, or related field.
   • 3–8 years of experience in Regulatory Affairs for medical devices (US and/or EU).
   • Hands-on experience with 510(k) submissions and EU MDR compliance.
   • Strong understanding of FDA regulations (21 CFR Part 807, 820) and EU MDR requirements.
   • Experience in technical documentation and risk management (ISO 14971).
   • Knowledge of quality standards such as ISO 13485.
   • Strong communication and coordination skills.
    
3. Preferred Skills:
   • Experience with De Novo or PMA submissions (US).
   • Familiarity with clinical evaluation reports (CER) and post-market surveillance (PMS).
   • Experience working with Notified Bodies and regulatory audits.
   • Ability to manage multiple projects and timelines effectively.

We are seeking a skilled Cybersecurity Analyst with expertise in Vulnerability Assessment and Penetration Testing (VAPT). The role involves identifying security vulnerabilities, performing penetration testing, and ensuring systems, networks, and applications are secure against potential threats.

1. Key Responsibilities:
   • Perform Vulnerability Assessment and Penetration Testing (VAPT) on web applications, mobile applications, networks, and systems.
   • Identify, analyze, and report security vulnerabilities with risk severity and remediation recommendations.
   • Conduct manual and automated penetration testing.
   • Use industry-standard tools (e.g., Burp Suite, Nessus, Nmap, Metasploit).
   • Validate and re-test vulnerabilities after fixes are implemented.
   • Prepare detailed VAPT reports and present findings to stakeholders.
   • Ensure compliance with security standards such as OWASP, ISO 27001, and PCI-DSS.
   • Collaborate with development and IT teams to improve security posture.
   • Stay updated with the latest cybersecurity threats, tools, and best practices.
    
2. Required Skills & Qualifications:
   • Bachelor’s degree in Computer Science, Cybersecurity, IT, or related field.
   • 2–6 years of experience in VAPT and penetration testing.
   • Strong knowledge of OWASP Top 10 vulnerabilities and security concepts.
   • Hands-on experience with penetration testing tools and techniques.
   • Understanding of network security, web security, and system vulnerabilities.
   • Good analytical and problem-solving skills.
   • Strong documentation and communication skills.
    
3. Preferred Skills:
   • Certifications such as CEH, OSCP, CISSP, or equivalent.
   • Experience in cloud security (AWS, Azure, GCP).
   • Knowledge of secure coding practices and DevSecOps.
   • Experience with API security testing.

We are seeking a skilled Medical Writer with experience in clinical and non-clinical
documentation. The role involves preparing high-quality scientific and regulatory
documents in compliance with global guidelines, supporting drug development and
regulatory submissions.

1. Key Responsibilities:
   • Prepare and review clinical documents such as Clinical Study Reports (CSRs), protocols, Investigator’s Brochures (IBs), and informed consent forms.
   • Develop non-clinical/toxicology documents including study reports, summaries, and overviews.
   • Author regulatory documents such as CTD modules (Module 2 summaries), briefing books, and submission documents.
   • Ensure all documents comply with ICH, GCP, and applicable regulatory guidelines.
   • Collaborate with cross-functional teams (Clinical, Regulatory, Biostatistics, Non-clinical teams).
   • Perform literature reviews and data interpretation for document preparation.
   • Ensure accuracy, consistency, and quality of scientific content.
   • Manage document timelines and support submission activities.
    
2. Required Skills & Qualifications:
   • Bachelor’s/Master’s/PhD in Pharmacy, Life Sciences, Medicine, or related field.
   • 2–8 years of experience in medical writing (clinical and/or non-clinical).
   • Strong understanding of ICH guidelines, GCP, and regulatory requirements.
   • Experience in writing CSRs, protocols, CTD summaries, and non-clinical reports.
   • Excellent writing, editing, and scientific communication skills.
   • Attention to detail and ability to meet deadlines.
    
3. Preferred Skills:
   • Experience with global regulatory submissions (US, EU, ROW).
   • Familiarity with document management systems and templates.
   • Ability to handle multiple projects and stakeholders.
   • Experience in publication writing is an added advantage.