DDReg pharma

Quailty Driven by Passion

Career Opportunities

Job Summary:

We are seeking a highly skilled and technically sound Senior Full-Stack Engineer with 4–6 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: 4–6 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 Summary: We are seeking a highly skilled and technically sound Senior Full-Stack Engineer with 4–6 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 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...

Full Time
Gurgaon
Posted 2 months ago

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 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 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...