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. Show more Show less
Job Summary We are looking for a dynamic and results-driven Digital Marketing Executive to join our team. This role requires a passionate marketer with a solid foundation in SEO and social media marketing. The ideal candidate will be responsible for executing SEO strategies and managing our social media presence to increase brand awareness, drive website traffic, and generate qualified leads. Seo Key Responsibilities: Conduct comprehensive keyword research, competitive analysis and implement on-page and off-page SEO strategies. Optimize website content, meta tags, images, content and URLs to improve search engine rankings. Monitor SEO performance using tools like Google Analytics, Search Console, SEMrush, Ahrefs, etc. Perform regular technical SEO audits and implement fixes. Stay up to date with the latest SEO trends and algorithm updates. Social Media Plan, create, and schedule engaging content for platforms such as LinkedIn, Twitter, Facebook, and Instagram. Manage day-to-day social media activities, including responding to comments and engaging with followers. Track and analyze performance metrics (engagement, reach, conversions) to improve campaign results. Coordinate with the design and content teams to create visually appealing and relevant social media posts. Execute paid social media campaigns when required. Qualifications Bachelor’s degree in Marketing, Communications, or a related field. 1–3 years of hands-on experience in SEO and social media marketing. Strong understanding of SEO best practices, tools, and Google algorithm updates. Proficiency in social media platforms and content creation tools. Excellent written and verbal communication skills. Analytical mindset with the ability to interpret data and generate insights. Preferred Skills Experience with Google Ads, Meta Ads Manager, and email marketing tools. Basic knowledge of HTML/CSS is a plus. Familiarity with marketing automation platforms and CRM tools. Employment Type Full-Time Location: Gurgaon (On-Site) Show more Show less
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. Related
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) Related
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) Related Assistant Manager – Regulatory Affairs – EU Job Title: Assistant Manager – Regulatory Affairs (EU & UK)Location: Gurgaon, Haryana (India)Experience: 4–6 YearsQualification: Master’s Degree in Pharmacy (M.Pharm or equivalent) Role OverviewWe 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,… May 22, 2025 Similar post Assistant Manager – API_RA 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… May 22, 2025 Similar post Senior Software Developer (MERN Stack) 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… July 7, 2025 Similar post
The Medical-Regulatory Writer Assistant Manager will be responsible for planning and managing Medico-Regulatory Writing for Regulatory compliance in accordance with applicable Regulatory Guidelines. You will be tasked with providing high-quality medical and scientific writing services, from planning and coordinating literature searches to delivering final drafts to both internal and external clients. Your role will also involve offering technical consultation, substantive advice on strategy, regulations, and industry best practices, and demonstrating expertise in subject matter and therapeutic areas. In addition, you will need to effectively manage medical writing projects to ensure the delivery of quality products within agreed timelines. Collaboration with internal and external clients will be essential, along with tasks such as writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports, and other relevant documents. You will also be responsible for conducting science reviews of aggregate reports produced by PV Associates and ensuring that all document outputs and processes align with client specifications, templates, and style guidelines. Furthermore, the role requires attending project initiation meetings, maintaining awareness of current regulatory guidance and medical information techniques, updating Aggregate Report Tracker, carrying out cases reconciliation periodically, and conducting detailed searches on regulatory agency websites for safety alerts. Mentoring Associates, overseeing training plans, and enhancing the skills of existing team members will also be part of your responsibilities. The ideal candidate should hold a Master's degree in Pharmacology/Pharmacy/Medicine with at least 5 years of experience, although an advanced degree is preferred. Previous experience in the pharmaceutical/CRO industry is advantageous, along with additional qualifications in medical writing such as AMWA, EMWA, or RAC. Strong data interpretation, medical writing, and project management skills are essential, as well as excellent interpersonal, negotiation, oral and written communication skills. Proficiency in Microsoft Word, PowerPoint, and Excel, as well as the ability to work effectively in a team-oriented environment, are also required. This position may occasionally require working in different time zones as needed. There are no direct reports for this role, and the location will be in Gurgaon.,
As the Finance Manager, you will be responsible for managing overall finance functions, including annual audits. You will be preparing various financial reports such as Revenue & Expense trends, Working Capital sheets, Cash flows, Balance sheets, and PnLs. In addition, you will oversee Invoicing, manage GST & GST returns, and support the Co CA with tax returns on time. Developing and implementing efficient internal controls and ensuring adherence to accounting and company policies and procedures will be a key part of your role. Your responsibilities will also include reviewing month-end financial statements, conducting variance analysis, and supervising accounts and taxation. You will be required to perform, review, and approve Internal Control Checklists, ensuring compliance with policies and procedures. Providing procurement support, controlling spending channels, and ensuring adherence to corporate procurement guidelines will be part of your day-to-day tasks. You will also support annual budget planning activities. To qualify for this role, you should have a Bachelor's Degree in Finance and/or Accountancy, along with 3-5 years of relevant experience. A good command of English and the ability to work independently are essential. Having a proven track record in financial management, including accounting, financial planning, reporting, and internal controls, is preferred. Knowledge of financial planning and analysis, application of metrics for performance improvement, and financial and business acumen are important for this role. Working knowledge of the service industry would be an added advantage. Strong communication skills, the ability to drive process improvement, and operate effectively within a complex organization are required. You should be able to translate corporate vision into results, possess strong Excel skills, and be willing to learn and operate various financial systems. This position is based in Gurgaon.,
The job involves reviewing technical documentation for regulatory filings in various markets such as EU, UK, and US, specifically focusing on Gap Analysis and Remediation for module 3 -API. You will be responsible for preparing and compiling Section 322, QOS & QbR to ensure they comply with regulatory guidelines and meet the highest quality standards. It is important to critically review documentation for internal consistency and adherence to relevant guidelines to uphold regulatory excellence. Your expertise in the subject matter and area is crucial, along with collaborating with internal and external clients. Effective communication is key to achieving operational excellence. You should possess a high level of knowledge of country regulations and regulatory guidelines, staying updated with changes on various agencies" websites. Candidates are required to have a Masters degree in Pharma or Msc Chemistry, along with 4 to 6 years of relevant experience. Strong technical data interpretation skills, interpersonal skills, and negotiation skills are essential. Excellent oral and written communication skills, including strong presentation skills, are necessary. Proficiency in global, regional, national document development guidelines is required, along with good computer skills and the ability to work in a team-oriented environment. The role may require working in different time zones as needed. The position is based in Gurgaon, Haryana, India.,
You will be responsible for conducting CMC review of technical documentation for regulatory filings in various markets such as EU & UK, US. This will involve performing Gap Analysis and Remediation for module 3 - API. You will also be tasked with preparing and compiling Section 322, QOS & QbR to ensure they adhere to applicable regulatory guidelines and maintain the highest quality standards. Your role will include critically reviewing documentation for internal consistency, alignment with relevant guidelines, and to uphold regulatory excellence. It is essential to demonstrate your subject matter expertise in this field. Collaboration with both internal and external clients is a key aspect of this role. You will be expected to support and facilitate effective communication that drives operational excellence. You must exhibit a high level of knowledge regarding country regulations and stay updated on regulatory guidelines from various agencies" websites. To qualify for this position, you should hold a Masters degree in Pharma or MSc Chemistry. Additionally, you should have previous experience equivalent to 4 to 6 years that equips you with the necessary knowledge and skills to excel in this role. Your success in this position will depend on your proficiency in technical data interpretation, interpersonal skills, negotiation skills, and oral/written communication skills. You must also possess significant knowledge of global, regional, national document development guidelines. Proficiency in using computer applications such as Microsoft Word, PowerPoint, Excel, and document management systems is essential. Working collaboratively in a team-oriented environment is a fundamental requirement for this role. Your ability to evaluate information systematically, deliver results effectively, and maintain a results-driven approach will be crucial. You should also demonstrate flexibility, adaptability, and the capability to work under pressure while delivering high-quality outputs within tight timelines. Occasionally, you may be required to work in different time slots to accommodate various time zones. The location for this position is in Gurgaon, Haryana, India.,
You will be responsible for the CMC review of technical documentation for regulatory filings across various markets including the US. This will involve conducting Gap Analysis and Remediation for Module 3 - CMC. Additionally, you will play a key role in the development and implementation of regulatory strategies, processes, and timelines for the grant of Marketing Authorization in regions such as Africa, GCC, LATAM, and ASEAN. Your tasks will include reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. It is essential to critically review documentation intended for submission to regulatory agencies to ensure internal consistency and adherence to relevant guidelines, thereby promoting regulatory excellence. You will be expected to demonstrate expertise in the subject matter and relevant areas, collaborate effectively with internal and external clients, and facilitate clear and efficient communication for operational excellence. A high level of knowledge regarding country regulations and regulatory guidelines, as updated from time to time on various agencies" websites, is also required. To qualify for this position, you must hold a Master's degree in Pharma and possess relevant experience equivalent to 7 to 10 years. Strong technical data interpretation skills, interpersonal skills, oral and written communication skills, and knowledge of US Regulations are essential requirements. Proficiency in using computer applications such as Excel, Outlook, and document management systems is necessary. Additionally, the ability to work effectively in a team-oriented environment, under pressure, and within tight timelines is crucial for this role. As part of the role, you may be required to work in slots catering to different time zones as needed. The position is based in Gurgaon, Haryana, India. Join us and contribute to our global regulatory team as an Assistant Manager in Regulatory Affairs, focusing on the US market and beyond.,
As a Medical-Regulatory Writer Assistant Manager, you will be responsible for planning and managing Medico-Regulatory Writing in compliance with applicable Regulatory Guidelines. Your duties will include providing high-quality medical and scientific writing, offering technical consultation and advice on strategy and regulations, demonstrating subject matter expertise, managing writing projects effectively to meet deadlines, collaborating with internal and external clients, and writing various types of reports such as CTD Modules, Safety Reports, and Aggregate Reports. You will also be required to conduct science reviews of aggregate reports, ensure document compliance with client specifications, attend project meetings, stay updated on regulatory guidance, maintain Aggregate Report Tracker, perform detailed searches on regulatory agency websites, mentor associates, and provide effective communication that leads to operational excellence. To qualify for this role, you should have a Master's degree in Pharmacology/Pharmacy/Medicine with at least 5 years of experience. An advanced degree is preferred, along with previous experience in the pharmaceutical/CRO industry. Additional qualifications in medical writing (AMWA, EMWA, RAC) would be advantageous. You should possess excellent data interpretation and medical writing skills, strong project management abilities, interpersonal and negotiation skills, and exceptional oral and written communication skills. Knowledge of global, regional, and national document development guidelines, along with proficiency in Microsoft Word, PowerPoint, and Excel, is essential. You should be able to work well in a team, handle pressure, and deliver quality work within tight timelines. Occasionally, you may need to work in different time zones. This position does not have any direct reports and is based in Gurgaon. If you meet the qualifications and possess the required skills and abilities, we invite you to apply for this challenging and rewarding role in the medical-regulatory writing field.,
As a Finance Manager, you will be responsible for managing the overall finance functions of the company, including annual audits and preparing various financial reports such as Revenue & Expense trends, Working Capital sheets, Cash flows, Balance sheets, and PnLs. You will also be in charge of managing Invoicing, GST, and GST returns. Your role will involve preparing documentation and supporting the Co CA with tax returns on time. In this position, you will be required to develop and implement efficient internal controls, ensuring adherence to accounting and other company policies and procedures. You will conduct month-end financial statements review and reporting, including variance analysis and account-level research. Supervising accounts and taxation will also be part of your responsibilities. Additionally, you will perform, review, and approve required Internal Control Checklists, ensuring compliance with necessary policies and procedures through oversight and field training. Providing procurement support and controls by reviewing and approving all channels of spending will be essential. You will also be responsible for supporting annual budget planning. To qualify for this role, you should hold a Bachelor's Degree in Finance and/or Accountancy and have at least 3-5 years of relevant experience. Proficiency in English and the ability to work independently are also required. Preferred candidates will have a proven track record in financial management, including accounting, financial planning, financial reporting, and internal controls. Knowledge of Financial Planning and Analysis, application of metrics to drive performance, financial and business acumen, and experience in the service industry are desired. The ideal candidate will possess strong communication skills to collaborate effectively in a diverse cross-functional environment. You should be able to drive process improvement as a change agent, operate within a complex and dynamic organization, and translate Corporate vision into results. Proficiency in Excel and the ability to learn and operate various financial systems are also essential for this role. This position is based in Gurgaon.,
The Project Lead Pharmacovigilance position at DDReg offers a compelling opportunity for you to advance your career in pharmacovigilance project management. As a crucial member of the Project Management team, you will play a key role in overseeing and directing all pharmacovigilance services. Your responsibilities will include serving as the primary contact for clients, ensuring project activities align with client needs and regulatory requirements, and maintaining high-quality work standards to achieve client satisfaction. Your key accountabilities in this role will involve closely managing client relations by acting as the main liaison between clients and project teams. You will be responsible for fostering strong communication and relationships with clients and internal teams, providing regular updates, and proactively resolving any issues that may arise. Additionally, you will be tasked with developing project scope and objectives, planning and tracking project activities, coordinating with cross-functional resources, and ensuring the timely delivery of high-quality pharmacovigilance work. To excel in this position, you should have 3-4 years of previous experience in Pharmacovigilance Project Management, preferably in a service provider or CRO environment. A background in Life Sciences or Biomedical field with a healthcare-related degree such as pharmacology, biology, biotechnology, or veterinary science is essential. You should possess a strong skill set that includes proficiency in various PV processes and regulations, excellent client-management skills, effective communication abilities, time management skills, and attention to detail. Advanced proficiency in verbal and written English, as well as knowledge of MS Office applications, is also required for this role. Join DDReg as a Project Lead Pharmacovigilance and take advantage of this opportunity to contribute meaningfully to the field of pharmacovigilance project management while elevating your career to new heights.,
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. Related Assistant Manager – Regulatory Affairs – EU Job Title: Assistant Manager – Regulatory Affairs (EU & UK)Location: Gurgaon, Haryana (India)Experience: 4–6 YearsQualification: Master’s Degree in Pharmacy (M.Pharm or equivalent) Role OverviewWe 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,… May 22, 2025 Similar post Manager – Regulatory Affairs – EM 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… May 22, 2025 Similar post Assistant Manager – API_RA 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… May 22, 2025 Similar post
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 Related