Career Openings
ISMS Manager
Job Summary:
DDReg Pharma Pvt Ltd is seeking a detail-oriented and proactive Information Security Analyst to join our team in Gurugram. The ideal candidate will be responsible for ensuring the integrity, confidentiality, and availability of information systems by identifying and mitigating security risks. The successful candidate will possess expertise in information security frameworks such as ISO 27001, SOC 2, and a strong understanding of third-party risk management.
Key Responsibilities:
- Vendor Risk Management: Oversee the management of all vendors, ensuring compliance with organizational security standards, effective communication, and adherence to service level agreements (SLAs).
- Risk Assessments: Conduct comprehensive risk assessments to identify vulnerabilities within the organization and implement effective mitigation strategies. Regularly evaluate organizational security posture and suggest improvements.
- ISO 27001 Compliance: Lead efforts in ensuring compliance with ISO 27001:2022 standards. Conduct internal audits and support external audits to ensure continuous adherence to the standards.
- Third-Party Risk Management (TPRM): Lead the TPRM onboarding and periodic review processes, ensuring third-party vendors meet required security standards and regulatory compliance.
- Incident and Problem Management: Analyze incidents and problems within the organization, identifying root causes and developing actionable plans to prevent future occurrences.
- Policy and Documentation Review: Review and update organizational policies and procedures to ensure alignment with ISO 27001 and other regulatory requirements. Maintain comprehensive documentation of all security-related activities.
- Collaboration & Reporting: Collaborate with internal teams and external auditors to ensure compliance with relevant frameworks. Prepare and present detailed reports on security incidents, risk assessments, and mitigation strategies.
- Training and Awareness: Facilitate training sessions for internal teams on information security best practices and compliance requirements, ensuring continuous education on security threats and mitigation measures.
Key Skills & Requirements:
- Proven experience in Information Security, including hands-on experience with ISO 27001, SOC 2, and ITGC frameworks.
- Strong understanding of third-party risk assessments and vendor management.
- Experience in Risk Assessment, Incident Management, and Root Cause Analysis.
- Certification: ISO 27001 Lead Auditor (preferred).
- Proficiency in creating and maintaining security documentation, policies, and procedures.
- Familiarity with NIST, GRC, and SOC 2 frameworks.
- Ability to work under pressure, manage multiple tasks, and handle sensitive information.
Educational Qualifications:
- Bachelor’s Degree (Mandatory):
B.Sc. in Information Technology, Computer Science, Cybersecurity, or related fields.
OR
B.Tech. / B.E. in Computer Science, Information Technology, or related engineering disciplines. - Master’s Degree (Preferred):
M.Sc. in Information Security, Cybersecurity, or related fields.
OR
MBA in Information Security (if focused on management aspects of ISMS). - Languages:
English: Full Professional Proficiency
Hindi: Full Professional Proficiency
Job Features
Job Summary: DDReg Pharma Pvt Ltd is seeking a detail-oriented and proactive Information Security Analyst to join our team in Gurugram. The ideal candidate will be responsible for ensuring the integri...
Project Manager – Regulatory Affairs
Job Summary:
We are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, ensuring timely and successful product registration, market authorization, and compliance with relevant regulatory requirements. The ideal candidate will have a deep understanding of global regulatory frameworks, exceptional project management skills, and experience working with cross-functional teams to deliver regulatory affairs services in the pharmaceutical industry.
As a Project Manager, you will be responsible for overseeing the full lifecycle of regulatory projects, ensuring alignment with market standards, timelines, and quality requirements. This role requires strong leadership, strategic thinking, and the ability to collaborate with various internal and external stakeholders to drive the successful delivery of regulatory affairs objectives.
Key Responsibilities:
- Project Management:
Lead and manage regulatory projects (e.g., drug registrations, labeling updates, product lifecycle management) in accordance with regulatory requirements.
Develop and maintain detailed project plans, including timelines, budgets, and resource allocation, to ensure successful project delivery.
Coordinate with internal teams (Regulatory Affairs, Clinical, CMC, QA, etc.) and external stakeholders (regulatory authorities, vendors, partners) to ensure regulatory submissions are prepared accurately and on time.
Monitor project progress, identify risks, and implement corrective actions to resolve any potential issues.
Ensure all regulatory activities are executed in compliance with local, regional, and global regulations and guidelines. - Regulatory Strategy & Compliance:
Provide guidance on regulatory strategy for new product development, life-cycle management, and post-market compliance.
Support the regulatory submission process by ensuring all required documents, data, and information are prepared, submitted, and tracked according to regulatory authority requirements.
Maintain an up-to-date understanding of global regulatory changes (FDA, EMA, ICH, etc.) and their impact on the organization’s products and projects. - Cross-functional Collaboration:
Work closely with R&D, quality assurance, manufacturing, and other departments to ensure regulatory considerations are incorporated throughout the product development lifecycle.
Foster strong relationships with regulatory agencies and external partners to influence and expedite approval processes. - Documentation & Reporting:
Ensure that regulatory submissions, dossiers, and project documentation are organized, complete, and compliant with regulatory guidelines.
Prepare and present regular project updates and reports to senior management and key stakeholders on project status, timelines, risks, and issues. - Continuous Improvement:
Identify areas for improvement in regulatory processes and propose solutions to increase efficiency and compliance.
Drive regulatory best practices and ensure adherence to internal SOPs, industry standards, and regulatory requirements.
Qualifications:
- Bachelor’s or master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
- Certification in Regulatory Affairs (e.g., RAC) preferred.
Experience:
- Minimum of 5-7 years of experience in Regulatory Affairs, with at least 3-5 years in project management in the pharmaceutical industry (CRO, Biopharma, or consulting firm experience preferred).
- Proven experience managing regulatory submissions (e.g., IND, NDA, MAA, etc.) in various regions.
- Strong understanding of global regulatory requirements, guidelines (FDA, EMA, ICH, etc.), and pharmaceutical industry standards.
- Demonstrated expertise in managing cross-functional teams, timelines, budgets, and project deliverables.
Skills:
- Strong project management skills, including proficiency in project management tools (e.g., MS Project, Jira, etc.).
- Excellent written and verbal communication skills, with the ability to effectively interact with senior stakeholders and regulatory authorities.
- Detail-oriented with strong organizational skills and the ability to manage multiple projects simultaneously.
- Ability to navigate complex regulatory environments and provide clear regulatory guidance.
- Strong problem-solving skills, with the ability to assess risks and implement mitigation strategies.
Personal Attributes:
- Leadership and team-oriented mindset.
- Strong analytical thinking and attention to detail.
- Ability to thrive in a fast-paced, dynamic environment.
- High level of integrity and ethical standards.
- Proactive and solution-oriented approach to problem-solving.
Job Features
Job Summary: We are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, ensuring timely and successfu...
Job Summary:
We are seeking a highly skilled and technically sound Senior Full-Stack Engineer with 4–7 years of hands-on experience in the MERN stack (MongoDB, Express.js, React.js, Node.js). This role is ideal for a candidate who thrives in a fast-paced environment, possesses a strong command of both front-end and back-end technologies, and has the leadership capability to manage and mentor a multidisciplinary team.
The selected individual will work onsite from our Gurgaon office and report directly to the CTO, playing a strategic role in shaping and delivering scalable software solutions, including integrations with AI/ML modules.
Key Responsibilities:
- Architect, develop, and maintain end-to-end web applications using the MERN stack.
- Lead technical development of both client-side interfaces and server-side logic with a strong emphasis on performance, scalability, and security.
- Collaborate with UI/UX designers to convert Figma prototypes into responsive, interactive web applications.
- Coordinate and manage a team of software developers and collaborate with AI/ML engineers on feature integration.
- Translate business needs into technical solutions and contribute to system architecture and roadmap decisions alongside the CTO.
- Conduct code reviews, establish coding standards, and drive technical excellence within the development team.
- Optimize application performance at both the front-end and back-end levels.
- Troubleshoot production issues and ensure high system reliability and availability.
- Manage sprint planning, task assignments, and timely delivery of development milestones.
- Continuously explore and evaluate emerging tools and technologies to improve development efficiency and product quality.
Skills and Qualifications:
- Education: B.Tech / MCA / BCA or equivalent degree in Computer Science or related discipline.
- Experience: 4–7 years of full-stack development experience with a strong command of the MERN stack.
- Proven experience leading development teams and managing cross-functional technical projects.
- Strong front-end development skills using React.js and Next.js, with proficiency in modern JavaScript, HTML5, and CSS3.
- Back-end expertise in Node.js and Express.js, with experience in designing RESTful APIs.
- Solid hands-on experience with MongoDB for database design, indexing, and performance tuning.
- Strong grasp of Data Structures and Algorithms, with the ability to write optimized, maintainable code.
- Familiarity with UI/UX best practices and collaboration tools like Figma.
- Proficiency in Git and collaborative version control workflows.
- Excellent problem-solving skills and ability to manage multiple tasks with minimal supervision.
- Strong communication, interpersonal, and team management skills.
- Knowledge of cloud platforms such as AWS, GCP, or Azure is a plus.
Nice to Have:
- Experience with DevOps practices, CI/CD pipelines, and containerization tools like Docker.
- Familiarity with Agile/Scrum methodologies.
- Experience in AI/ML-based projects or integrating intelligent modules into full-stack applications.
What We Offer
- Opportunity to work closely with the CTO and contribute to key architectural and strategic decisions.
- A collaborative and fast-growing tech environment with real impact on product innovation.
- Career growth opportunities with leadership responsibilities.
- Competitive salary and performance-driven incentives.
Location Note:
This is a full-time, onsite role based in our Gurgaon office. Only candidates comfortable with working from the office should apply.
Job Features
Job Summary: We are seeking a highly skilled and technically sound Senior Full-Stack Engineer with 4–7 years of hands-on experience in the MERN stack (MongoDB, Express.js, React.js, Node.js). This r...
Job Descriptions
- CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC
- Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN.
- Review of CTD dossiers , variations, change controls, renewals and ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
- Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
- Demonstrate subject matter and area expertise.
- Collaborate with internal and external clients,
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
Education & Experience
- Master’s degree in Pharma
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7 to 10 years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Excellent interpersonal skills including problem solving
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of US Regulations
- Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Other requirements
As may be required from time to time – the incumbent may be required to working slots catering to different time zones
Location
Gurgaon, Haryana (INDIA)
Job Features
Job Descriptions CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC Development and implementation of regula...
Job Title: Assistant Manager – Regulatory Affairs (EU & UK)
Location: Gurgaon, Haryana (India)
Experience: 4–6 Years
Qualification: Master’s Degree in Pharmacy (M.Pharm or equivalent)
Role Overview
We are seeking a proactive and detail-oriented Assistant Manager – Regulatory Affairs to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the EU & UK markets, ensuring compliance with regional and international guidelines.
Key Responsibilities
Conduct comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets.
Perform Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards.
Develop and implement regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications.
Prepare and compile new CTD dossiers, variations, and renewals ensuring full compliance with applicable EMA/MHRA regulatory requirements and internal quality standards.
Critically review documentation to ensure internal consistency, compliance with regulatory expectations, and support regulatory excellence.
Collaborate with cross-functional teams including R&D, QA, QC, Manufacturing, and external stakeholders for timely and accurate data collation and submissions.
Ensure effective and efficient communication across teams to facilitate streamlined project execution and meet submission timelines.
Maintain high-level knowledge of current country-specific regulations, keeping track of regulatory updates through respective health authority websites (e.g., EMA, MHRA).
Education & Experience
Master’s degree in Pharmacy or equivalent qualification.
4 to 6 years of relevant experience in Regulatory Affairs, with a focus on EU and/or UK submissions.
Equivalent combinations of education, training, and practical experience may also be considered.
Key Skills & Competencies
Strong technical skills in data analysis and interpretation of regulatory documentation.
Excellent interpersonal and problem-solving skills with a proactive and solution-oriented approach.
Effective negotiation and communication skills for liaising with internal teams and external agencies.
Proficient in drafting and reviewing documents in line with global, regional, and national regulatory standards.
Expertise in document management systems and tools like Excel, Outlook, PowerPoint, and Word.
Strong presentation and reporting skills with the ability to explain complex regulatory concepts clearly.
Demonstrated ability to analyze data systematically, apply regulatory logic, and compile well-organized submissions.
Collaborative, results-driven, and self-motivated with the flexibility to adapt to shifting priorities.
Capable of delivering high-quality outputs under pressure and within aggressive timelines.
Other Requirements
Flexibility to work in cross-time-zone schedules, as needed to support global project coordination or agency interactions.
Why Join Us?
Be part of a high-performing regulatory team that plays a critical role in bringing impactful pharmaceutical products to patients globally. Work in a collaborative, fast-paced environment where your expertise shapes international market access strategies.
Job Features
Job Title: Assistant Manager – Regulatory Affairs (EU & UK) Location: Gurgaon, Haryana (India) Experience: 4–6 Years Qualification: Master’s Degree in Pharmacy (M.Pharm or equivalent) Rol...
Job Descriptions
- CMC review of technical documentation for regulatory filings to various markets – market: EU & UK, US- Gap Analysis and Remediation for module 3 -API
- Prepare and compile Section 322, QOS & QbR ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
- Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
- Demonstrate subject matter and area expertise.
- Collaborate with internal and external clients,
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
Education & Experience
- Master’s degree in Pharma, Msc Chemistry
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 6 years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities
- Excellent technical data interpretation skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Other requirements
As may be required from time to time – the incumbent may be required to working slots catering to different time zones
Location
Gurgaon, Haryana (INDIA)
Job Features
Job Descriptions CMC review of technical documentation for regulatory filings to various markets – market: EU & UK, US- Gap Analysis and Remediation for module 3 -API Prepare and compile Section...