Career Openings
Job Descriptions
- Provides regulatory publishing and submission support and oversight.
- Publishes Regulatory documents with Docubridge software application for initial submissions as well as, routine/ maintenance submissions to support active applications such as supplements and periodic reports.
- Trouble-shoots issues related to the published submissions.
- Collaborate with submission content contributors, regulatory leads and project management in the planning and preparation of submission components.
- Manage and execute assembly, publishing and timely submission of regulatory applications.
- Provides guidance (and where necessary training) to Regulatory Affairs staff on all aspects of submission formats/requirements and publishing related software/tools as and when required.
- Act as a Subject Matter Expert for publishing tools and standards.
Education & Experience
- Bachelor’s degree in pharmacy, Life Sciences, Biotechnology, Chemistry, or related scientific field. A master’s or higher is preferred.
- Hands‐on experience in publishing software (Lorenz is preferred) for submitting dossiers for US (FDA) and EU (EMA or national authorities).
- Strong knowledge of eCTD and validation requirements.
- Excellent written and spoken English; strong documentation skills.
- Minimum 2-5 years of publishing experience, with substantial exposure to the validator tools.
Location
Gurgaon, Haryana (Onsite) (INDIA)
Job Features
Job Descriptions Provides regulatory publishing and submission support and oversight. Publishes Regulatory documents with Docubridge software application for initial submissions as well as, routine/ m...
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...
Sr. Manager-Regulatory Affairs- US/EU
Experience: -15+ Years
Location: Gurgaon
We are looking for an experienced and accomplished Senior Manager – Regulatory Affairs (CMC) with deep expertise in US and EU regulatory frameworks. The role will drive regulatory strategy, dossier submissions, and lifecycle management activities across these key markets, ensuring compliance and regulatory excellence. The ideal candidate will bring 15+ years of proven experience in regulatory affairs, with a strong command of CMC regulations and a successful track record of managing complex global submissions.
Roles & Responsibilities
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Lead CMC review of technical documentation for regulatory filings in US and EU markets, including Gap Analysis and Remediation for Module 3 (CMC).
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Develop and implement regulatory strategies, processes, and timelines for new product registrations, variations, renewals, and post-approval changes in the US and EU.
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Oversee the preparation, review, and submission of CTD dossiers, ensuring conformance with FDA, EMA, and ICH guidelines.
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Critically evaluate submission documentation for scientific accuracy, compliance, and internal consistency.
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Provide regulatory intelligence by tracking changes in US and EU regulations, guidelines, and best practices.
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Collaborate closely with cross-functional teams (R&D, QA, Manufacturing, and Commercial) to ensure regulatory strategies are aligned with business objectives.
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Represent the company in discussions with regulatory authorities (FDA, EMA, and other relevant agencies).
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Mentor and guide junior regulatory team members, fostering a culture of regulatory excellence.
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Education & Experience
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Master’s degree in Pharmacy (Pharma) or a related field.
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15+ years of regulatory affairs experience, with significant exposure to US and EU CMC submissions.
Knowledge, Skills & Abilities
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In-depth knowledge of US FDA, EMA, and ICH CMC guidelines.
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Strong ability to interpret and analyze complex technical and scientific data.
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Exceptional oral and written communication skills, with strong presentation abilities.
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Proven leadership and mentoring skills with a collaborative, results-driven style.
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Excellent problem-solving and decision-making capabilities.
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Proficiency with document management systems and Microsoft Office Suite (Word, PowerPoint, Excel, Outlook).
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Ability to manage multiple priorities and deliver high-quality outputs under pressure.
Why Join Us?
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Play a key leadership role in shaping regulatory strategies for high-priority US and EU markets.
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Opportunity to lead impactful submissions and contribute to global product approvals.
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Exposure to cross-functional teams and business strategies.
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Work in a collaborative environment with a focus on innovation and regulatory excellence.
Job Features
Sr. Manager-Regulatory Affairs- US/EU Experience: -15+ YearsLocation: Gurgaon We are looking for an experienced and accomplished Senior Manager – Regulatory Affairs (CMC) with deep expertise in US ...
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 Purpose:
We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for Canada Markets.
Key Responsibilities:
- Regulatory Compliance:
In-depth knowledge of Health Canada regulations, guidance documents, and submission formats. and will be responsible for preparing and submitting regulatory documentation for ANDS, maintaining compliance records, and liaising with regulatory agencies. - eCTD/CTD Sequence Review:
Maintain up-to-date knowledge of eCTD requirements and review of the sequence to ensure submission quality and compliance with regulatory standards. - Query Handling & Documentation:
Draft and review regulatory authority responses. Ensure clarity, regulatory alignment, and timely submission. - Functional File Preparation:
Handle electronic publishing tasks including hyperlinking, bookmarking, redactions, and formatting. Ensure technical accuracy and reduce rework. - Artwork & Labeling Review:
Prepare label texts and review of artworks. Ensure accuracy, consistency, and regulatory compliance. - Project Tracking & Documentation:
Maintain trackers, task planners, product history logs, and query records. Participate in client meetings and contribute to regulatory planning. - Team Collaboration & Communication:
Collaborate with internal stakeholders and external clients. Ensure timely follow-ups, documentation clarity, and professional engagement.
Educational Qualifications: B.Pharm / M.Pharm
Why Join Us
- Opportunity to contribute to key regulatory submissions
- Exposure to global health authority expectations
- Skill development and continuous learning environment
- Collaborative work culture
Job Features
Job Purpose: We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candi...
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 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...
Sr. Associate_ Medical Writing_ RA ( 3+ Yrs)
Job Purpose:
DDReg Pharma Pvt Ltd is seeking an experienced Regulatory Affairs Medical Writer responsible for drafting, reviewing, and ensuring the accuracy of scientific and regulatory documents in alignment with global standards. The role involves preparation of complex CTD modules, quality control of submissions, gap analysis, and support in responding to regulatory queries. The ideal candidate will collaborate cross-functionally and support team development and process improvement.
Key Responsibilities:
- Authoring & Review of Regulatory Documents
•Draft high-quality medical and regulatory documents in accordance with global guidelines.
•Prepare complex regulatory documents such as:
-- Module 2 components (Quality Overall Summary / Nonclinical Overview / Clinical Overview)
--Regulatory strategy reports
•Ensure consistency, scientific accuracy, and regulatory compliance across documents. - Quality Control (QC) of Documents
•Perform QC review of simple and complex documents including:
--SPC, PI, PIL, RMP
--Compiled modules for small molecules and biosimilars
--SPL, BE templates, TIF
--Aggregate reports, Expert reports
•Ensure documents are delivered with high quality and within agreed timelines. - Gap Analysis
•Perform gap assessment for small molecules and biosimilar products.
•Evaluate non-clinical and clinical data provided by clients to identify deficiencies affecting product submission/approval.
•Draft structured gap reports/sheets and propose corrective actions. - Query Response & Literature Support
•Support regulatory query responses by evaluating existing documents and addressing authority/client questions.
•Conduct literature searches to update documentation and prepare query response reports as required.
•Work with cross-functional teams to ensure clarity and customer satisfaction. - Mentoring & Training
•Support resolution of technical/medical doubts raised by team members.
•Provide on-the-job training and guidance to direct reportees.
•Identify training needs for self and team on a quarterly basis.
Key Skills & Requirements:
- Bachelor’s/Master’s/PhD in Life Sciences, Pharmacy, Biotechnology, or related field.
- 3–7 years of experience in regulatory/medical writing.
- Strong understanding of CTD format and global regulatory guidelines (ICH, FDA, EMA, CDSCO).
- Hands-on experience in:
--Module 2 documents
--Data analysis for gap assessment
--QC of regulatory deliverables - Excellent written communication, analytical skills, and attention to detail.
- Proficiency in MS Office and documentation systems.
Why Join Us
- Opportunity to contribute to key regulatory submissions
- Exposure to global health authority expectations
- Skill development and continuous learning environment
- Collaborative work culture
Job Features
Job Purpose: DDReg Pharma Pvt Ltd is seeking an experienced Regulatory Affairs Medical Writer responsible for drafting, reviewing, and ensuring the accuracy of scientific and regulatory documents in a...