333 Regulatory Submissions Jobs - Page 7

Role Overview: As a Lead Statistical Programmer in the clinical data field, you will be responsible for overseeing programming activities related to clinical trials, regulatory submissions, and integrated analyses. Your role will involve leading a team, ensuring the delivery of high-quality work, and establishing efficient programming standards to support drug development. Key Responsibilities: - Lead statistical programming activities for a compound or therapeutic area. - Manage, mentor, and guide a team of statistical programmers. - Create and validate analysis data sets (ADaM), tables, listings, and figures (TFLs) following CDISC standards. - Develop and validate Integrated Summary of Saf...

As a Statistician I at YouV, you will play a crucial role in conducting statistical analysis for clinical trials, contributing to the interpretation of study results, and ensuring data quality and integrity. Your responsibilities will include: - Assisting in statistical analysis for clinical trials. - Performing data cleaning and validation. - Generating summary tables, figures, and listings. - Assisting in the development of statistical analysis plans and study protocols. - Collaborating with cross-functional teams to ensure data quality and integrity. - Contributing to the interpretation of study results. - Staying updated with relevant regulations and industry best practices. Qualificatio...

Regulatory Affairs Management- Understands the regulatory framework, including regional trends, for various types of applications and procedures for biological therapeutic products (Biologics, Biosimilar, Novel Biologics and Vaccines) in India and ROW markets. Provides regulatory input on procedural and documentation requirements as defined by Health Authorities such as Indian regulatory authority, Emerging markets and ROW countries. Review of documents (e.g. RCGM-PCS, CTA, MAA, PAC, response documents, study protocols, regulatory maintenance documents, PSURs, etc.). Analysis of regulatory procedures and special designations used during development, authorizations and extension of the produc...

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, a...

As an Associate Statistician at our organization, your role will involve assisting in conducting statistical analysis for clinical trials. You will be responsible for performing data cleaning and validation, as well as generating summary tables, figures, and listings. Additionally, you will collaborate with cross-functional teams to ensure data quality and integrity, contribute to the interpretation of study results, and stay updated with relevant regulations and industry best practices. Your qualifications should include a Bachelor's degree in Statistics, Biostatistics, or a related field. You will have the opportunity to work under the guidance of senior statisticians, conduct statistical ...

Tracking of Regulatory emails and ensuring revert has been provided to Exchange Insider Trading Regulation Approvals Advertisement approvals Regulatory Submissions - Exchanges and Depositories ================================================= Educational Qualifications: Graduate/Post Graduate Experience: 5 to 6 year experience in Broking firm Domain Knowledge: Broking Industry, SEBI Regulations NISM IIIA to be cleared mandatorily

Location: Gurgaon Regulatory and Safety Affairs is a critical function within R&D: a key partner in developing the right portfolio strategy for brilliant innovation, activation in our markets and secure the products during all product life cycle. We actively engage externally with stakeholders and regulators to anticipate and credibly influence changes to the regulatory environment, and we bring that regulatory intelligence back to Reckitt to drive better informed business decisions. We lead the thinking internally about what is possible and put forward ideas that become reality, acting as stewards of our brands and our company to deliver compliant and competitively positioned products to th...

Role & responsibilities Hiring candidates with experience in CMC Regulatory Affairs in Pharmaceutical Industry across regulated and semi regulated regions with hands on experience into - Preparing submission content plans for CMC submissions including, post approval changes, renewals, product renewals, Module 3 baselines, and annual report/notifications. Execute regulatory team activities as directed to achieve submission approval for products in regulated and semi regulated regions. Review quality documents for post approval submissions as above. Author high quality Module 3 and Module 2 section /summaries. Maintains the general knowledge of CMC/M3 regulations and guidance for Injectables. ...

You will be responsible for developing, validating, and applying pharmacokinetic and pharmacodynamic models (PopPK and PBPK modelling) to support drug development programs. This includes conducting and presenting pharmacokinetic modelling and simulation (M&S) analysis to management and technical teams for project advancement. You will also predict human pharmacokinetics based on in-silico, in-vitro, and in-vivo data, including dose scaling and profile prediction. Additionally, you will conduct IVIVE and IVIVC and work closely with cross-functional teams, including preclinical, clinical, and regulatory teams, to guide decision-making and project direction. Utilizing software tools such as Win...

Job Title: Study Start-up and Regulatory Submission Manager Location: Navi Mumbai, India Experience Required: 5 10 years Employment Type: Full-Time Working Days: 2nd & 4th Saturdays; All Sundays Off Job Description We are seeking an experienced Study Start-up and Regulatory Submission Manager to join our clinical operations team in Navi Mumbai. The ideal candidate should have strong expertise in India-specific clinical trial operations , with proven experience managing regulatory submissions and study start-up activities . Key Responsibilities: Lead and manage Clinical Trial Applications (CTA) and regulatory submissions in compliance with Indian regulatory requirements. Drive clinical study ...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. You will perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussions for comment resolution. Additionally, you will write various safety ...

Position- Executive/Sr. Executive Dept.-Regulatory Affairs Key Responsibilities Act as the first point of support for Business Development Managers on product-related queries from India. Coordinate and organize audits of supplier production facilities to ensure compliance with international standards. Gain exposure to and support during international regulatory audits (USFDA, WHO, ANVISA, EDQM). Understand and translate client quality parameters for raw materials, ensuring supplier adherence. Monitor supplier manufacturing processes for compliance with national and global standards. Assist in preparing and managing documentation for specification setting, change controls, regulatory submissi...

Role & responsibilities Job description Perform protocol for drug excipient compatibility studies and submit the protocol for review and approval Complete lab. experiment hands-on independently (Lab scale to exhibit batch and query handling). Dosage forms experience: Injectables predominantly more than 90% in career. Perform formulation development activities on differentiated formulations and innovative technologies as part of product development. Carry out /Support Scientific literature search (CVM/USFDA/Daily-med/publications). Follow good laboratory practices, good documentation practices (online LNB writing) and maintain the logbooks and forms for equipment/instruments. Compilation, int...

As a Regulatory Affairs Manager at Vibcare Healthcare, a leading pharmaceutical manufacturer committed to enhancing health outcomes through innovative and quality assured pharmaceutical products, your primary responsibility will be ensuring regulatory compliance, managing regulatory requirements, overseeing regulatory submissions, and maintaining the quality system. You will play a crucial role in upholding unparalleled transparency and quality in all our offerings, certified by WHO-GMP standards. To excel in this role, you should possess expertise in regulatory compliance, regulatory requirements, regulatory affairs, regulatory submissions, and quality system management. Your strong attenti...

As a leading global contract research organization (CRO) dedicated to scientific excellence and backed by years of expertise in clinical development, Fortrea offers a diverse array of clinical development, patient access, and technology solutions in over 20 therapeutic areas. Operating in approximately 100 countries, Fortrea is revolutionizing drug and device development worldwide. Your responsibilities will include performing various tasks such as generating reports from databases or safety systems, managing data requests, conducting sales data calculations, and conducting regulatory website searches. You will also have the opportunity to contribute to different safety reports for internati...

About the Opportunity Job Type: Fixed Term Contractor Contract duration : 7 months. Application Deadline: 08 September 2025 Job Description Title Senior Associate - GCSS Operations Department General Counsel Shared Services Location India Reports To Manager, GCSS Operations Level Grade 3 We're proud to have been helping our clients build better financial futures for over 50 years. How have we achieved this By working together - and supporting each other - all over the world. So, join our General Counsel Shared Services team and feel like you're part of something bigger. General Counsel (GC) is a trusted advisor to all parts of FIL, providing high-value independent advisory and assurance expe...

Job Description: As a Regulatory Affairs Manager at McW Healthcare, you will play a crucial role in ensuring regulatory compliance and maintaining quality systems in our pharmaceutical company based in Indore. Your responsibilities will include handling regulatory requirements, submissions, and overseeing day-to-day operations related to regulatory affairs. To excel in this role, you should possess strong skills in regulatory compliance, regulatory requirements, and regulatory submissions. A deep understanding of quality systems is essential to maintain the high standards of our WHO approved facility. Attention to detail and analytical abilities will be key as you navigate the complexities o...

The Associate Director Biostatistics position based in Ahmedabad requires a candidate with an MSc or PhD in Biostatistics/Statistics and at least 12 years of experience in CROs, Bio-tech, Pharma, or Biopharmaceuticals. As an Associate Director Biostatistics, your main responsibilities will include leading and overseeing all statistical activities for clinical studies. This involves tasks such as study design, analysis plans, reporting, and publications. You will be managing a team of statisticians and programmers to ensure the timely delivery of high-quality work. Additionally, you will provide statistical input on protocols, sample size calculations, and randomization schemes, as well as de...

You are an experienced Associate Director - Biostatistics who will be joining a leading client in the pharmaceutical industry. Your role will be crucial in clinical development, involving tasks such as contributing to trial design, analysis planning, interpretation of results, and regulatory submissions. Your key responsibilities will include collaborating on innovative and efficient clinical trial designs to ensure alignment with study objectives. You will independently author and review protocols, statistical analysis plans, and clinical study reports. Providing statistical leadership in regulatory interactions, publications, and presentations will also be part of your role. Additionally, ...

Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory s...

Regulatory affairs professional with experience in managing product listings for different markets and ensuring full compliance with all regulations. Proven track record of collaborating with renowned global cosmetic brands to navigate and meet regulatory requirements across multiple regions, including the USA, Canada, Australia, New Zealand and Middle East. Proficient in cosmetic regulations, including several regulations and versed with interpreting and applying recent regulatory updates. Highly skilled in managing compliance with state-specific regulations. Adept at leading cross-functional teams to support regulatory submissions and ensure product compliance, driving efficiency and marke...

You will be joining our Clinical Operations team in India, Mumbai as a full-time Experienced Study Start-Up Submissions Coordinator. Your role will be crucial in completing tasks and projects essential to our company's success. If you are looking for a rewarding career where you can utilize your expertise and further develop professionally, this opportunity is for you. At our company, we value expertise and empower our teams to leverage their unique skills and experience in research, problem-solving, and supporting our business partners. Our employees embody our values, work diligently, meet high expectations, and are rewarded with engaging projects, career progression, and exposure to globa...

As a Senior Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications such as INDs, IMPDs, CTAs, BLAs, and MAAs. Your responsibilities will include developing and ensuring the completeness of CMC sections within IND and IMPD applications while adhering to regulatory guidance from FDA, EMA, and ICH. Your expertise in analytical method development, validation, comparability, biosimilarity assessments, upstream and downstream process development will be essential. Furthermore, you will provide peer review and mentorship to junior writers or team members to ...

The role of Global Strategy Leader is a remote position responsible for overseeing and implementing regulatory strategies for the global pharmaceutical portfolio of the company. Your primary focus will be on shaping regulatory decisions, managing complex global submissions, and ensuring successful product development, approval, and market access for the company's pharmaceutical products. In this role, you will collaborate closely with internal and external stakeholders to align regulatory strategies with business objectives and drive the timely delivery of high-quality pharmaceutical products. Your key responsibilities will include leading the development of global regulatory strategies, col...

As a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations), your main responsibility will be to develop and execute global regulatory strategies for combination product devices. You will play a crucial role in ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. To excel in this role, you should have a minimum of 5 years of regulatory affairs experience in biosimilars, biologics, or combination product development. Your expertise will be instrumental in providing regulatory guidance on device design, human factors, risk management, and manufa...