8 Submission Management Jobs

As a Regional Submission Manager - Sponsor-dedicated with CTIS experience at Syneos Health, you will play a crucial role in driving regional submission management strategy and activities for assigned protocols. You will collaborate with major functional areas, including SSU and Study Management, regarding essential core documents and local documentation needed from relevant supplier lines across both HA and EC submission and translation processes. Your responsibilities will include partnering with study teams to manage required regulatory activities, standards, and deliverables associated with CTA submission development. You will be responsible for authoring Annex I and completing relative associated documentation as required. Additionally, you will lead global team efforts to ensure high-quality components and submissions that are compliant with industry, agency, and format guidelines, regulatory strategies, policies, and timelines. In this role, you will prepare, review, and support submissions to HA/Regional CTA Hub to obtain all necessary authorizations/approvals related to the clinical trial conduct. You will also be responsible for coordinating translations for core documents required for submission and managing the compilation for core package build, contributing to CTA and authoring documentation as necessary. Furthermore, you may act as a local country liaison when required and escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities. To qualify for this position, you should have a Bachelor's Degree (Higher Degree Preferred) and independent CTIS experience in initial submission and substantial amendments. You should have the ability to work on multiple highly complex projects simultaneously and possess a strong knowledge of the drug development process, regulatory sciences, CTA and submission management, and publishing. It is essential to have an in-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experience in process development and new technology implementation. Additionally, you should be able to operate seamlessly and influence direct and indirect reports across the organization. Demonstrated understanding of regional and national regulator filing guidelines and dossier requirements is required, along with the ability to lead and deliver through others in a matrix model. Strong decision-making skills in ambiguous or urgent circumstances, excellent communication, presentation, and interpersonal skills, as well as quality-driven and negotiating abilities are also essential for this role. Join Syneos Health to be part of a dynamic team that is passionate about accelerating customer success and changing lives through innovative clinical development solutions. Discover the rewarding career opportunities that await you at Syneos Health.,

As a Regulatory Compliance Specialist, your primary responsibility will be to ensure that company products adhere to relevant regulatory requirements, including those stipulated by USFDA, FDA, EMA, and local regulatory bodies. You will be tasked with preparing and submitting regulatory documents such as INDs, NDAs, and MAAs to regulatory agencies. Additionally, you will play a pivotal role in developing and executing regulatory strategies that support product development and commercialization efforts. Your role will also involve staying abreast of evolving regulatory standards and providing guidance to internal stakeholders based on regulatory intelligence. You will coordinate and oversee regulatory audits and inspections, as well as review and approve product labeling and advertising materials to ensure compliance with regulations. Regular communication with regulatory agencies, such as the FDA, to address inquiries and issues will be part of your duties. Furthermore, you will be responsible for managing regulatory documentation, including submissions, approvals, and correspondence. Providing regulatory training and guidance to internal teams and monitoring company activities for compliance with regulatory requirements are also integral aspects of this role. This is a full-time, permanent position with a day shift schedule and a yearly bonus. The work location for this role is in-person.,

Note : The selected candidate must be willing to visit the manufacturing facility in Vasanthanarsapura, Tumkur at least two days a week and/or as required based on operational and regulatory needs. Job Title : Regulatory Affairs Manager Location : Jayanagar 2nd block, Bengaluru/Vasanthnarasapura KIADB Industrial Area, Tumkur, Karnataka Experience : 12 - 15 years experience Qualification : Bachelors / Master&aposs degree in Organic Chemistry. Industry : API (Active Pharmaceutical Ingredient) Manufacturing Compensation : - Compensation commensurate with the experience and qualifications of the candidate About Natural Biogenex Pvt. Ltd. (NBPL) Natural Biogenex Pvt. Ltd. (NBPL), a subsidiary of Natural Capsules Limited, is committed to quality, compliance, and innovation. Our state-of-the-art facility in Tumkur, Karnataka, operates under stringent Good Manufacturing Practices (GMP), ensuring the highest quality standards for pharmaceutical ingredients. To strengthen our Quality Control team, we are seeking a highly motivated and detail-oriented Executive QC who will play a crucial role in ensuring the quality, compliance, and accuracy of laboratory operations under cGMP and regulatory requirements. Position Summary: The Regulatory Affairs Manager oversees the regulatory submission processes, ensures compliance with all applicable regulations, and manages the regulatory strategy for pharmaceutical products. This role involves working closely with various departments, including R&D, Quality Assurance, and Marketing, to facilitate the development and commercialization of pharmaceutical products. Key Responsibilities: Note : The selected candidate must be willing to visit the manufacturing facility in Vasanthanarsapura, Tumkur at least two days a week and/or as required based on operational and regulatory needs. Regulatory Strategy Development : Develop and implement regulatory strategies for drug development and approval. Guide regulatory requirements and compliance to internal teams. Submission Management : Prepare and submit regulatory documents to health authorities (e.g., IND, NDA, BLA). Ensure timely and accurate submission of regulatory applications and amendments. Communication with Regulatory Authorities : Act as the primary point of contact with regulatory agencies. Manage and facilitate interactions with regulatory authorities, including meetings and responses to inquiries. Regulatory Compliance : Monitor changes in regulations and guidance to ensure compliance. Conduct audits and assessments to ensure adherence to regulatory requirements. Cross-Functional Collaboration : Work closely with R&D, Quality Assurance, and Marketing teams to ensure regulatory considerations are integrated into product development. Provide training and support to staff on regulatory processes and compliance. Project Management : Manage multiple regulatory projects simultaneously, ensuring timelines and deliverables are met. Coordinate with cross-functional teams to facilitate project milestones. Documentation and Record-Keeping : Maintain accurate records of regulatory submissions and communications. Prepare and review regulatory documentation for accuracy and completeness. Qualifications: Education: Bachelors / Master&aposs degree in Organic Chemistry Experience: Minimum of 12 - 15 years of experience in regulatory affairs within the pharmaceutical industry for filing of products in various regulatory agencies. Knowledge: Strong understanding of regulatory guidelines and compliance requirements (FDA, EMA, etc.). Skills: Excellent communication, organizational, and project management skills. Ability to work collaboratively in a fast-paced environment. Why Join Us ???? Be a part of a leading API manufacturing company with cutting-edge technology and compliance standards. ???? Work in a state-of-the-art Quality Control Laboratory with global regulatory standards. ???? Opportunity to contribute to regulatory audits and pharmaceutical quality excellence. ???? Competitive salary and professional development opportunities. Show more Show less

Regulatory Consultant (EU OTC) Responsibilities: Submission support: Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc. Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA. Prepare cover letter, application form and relevant Module 1 documents for variations. Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing. Work with regulatory team to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks. Regulatory review of submission documents for compliance. Work with cross-functional teams or local affiliates for submission documents and verification of packages. Updating relevant submission tracker. PSUR submission support: Review of EURD updates Tracking licenses for DLP and PSUR submission. Review of draft PSUR document for accuracy of the data. Co-ordinate with different stakeholders for safety related information for PSUR Support submission and handling of queries for PSUR Renewal support: Tracking of licenses for registration and approval. Tracking of approval validity of licenses and renewal timelines. Planning for renewal submission. Co-ordination with cross-functional team for Renewal documentation. Co-ordination with Local RA lead for Renewal documentation and submission. Preparation of Renewal package. Submission of Renewal to health authority and post submission activity. Deliverables: Provide weekly updates (at a minimum or based on client requirement) to relevant colleagues or Project Manager on project status. Internal & Confidential [not for external circulation] Ensure that regulatory standards and timelines are met for all projects. Planning and tracking the status of ongoing regulatory projects Use of regulatory database and IT tools where relevant. Project review every quarter on performance feedback and scope of improvement. Experience/Qualifications: Minimum B.S. Chemistry, Biology, or related fields Minimum of 4-5 years of experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience and specific interactions with a Regulatory Affairs Department by providing source documentation to CMC, Quality, or Regulatory Operations. Show more Show less

The Engine Room Role" focuses on the importance of having a strong and efficient process behind every successful event. ADDY Events is looking for a GeM Portal Operations Specialist to join their team and play a vital role in their operations. As a GeM Tender Expert, you will be responsible for managing tender bids on GeM, handling vendor onboarding and compliance, collaborating with the creative and planning team, and ensuring timely and compliant submissions. This role will be based on-site at the Greater Noida office with an expected start date as soon as possible. The compensation for this position will be based on your experience and skills. If you are detail-oriented, reliable, and tech-savvy, you will thrive in this role and contribute significantly to the success of ADDY Events.,

As the Regulatory Affairs Manager at Natural Biogenex Pvt. Ltd. (NBPL), you will be responsible for overseeing the regulatory submission processes, ensuring compliance with all applicable regulations, and managing the regulatory strategy for pharmaceutical products. Your role will involve working closely with various departments such as R&D, Quality Assurance, and Marketing to facilitate the development and commercialization of pharmaceutical products. Your key responsibilities will include developing and implementing regulatory strategies for drug development and approval, guiding regulatory requirements and compliance to internal teams, preparing and submitting regulatory documents to health authorities, managing communication with regulatory authorities, monitoring changes in regulations to ensure compliance, working collaboratively with cross-functional teams, managing multiple regulatory projects simultaneously, and maintaining accurate records of regulatory submissions and communications. To excel in this role, you should possess a Bachelor's or Master's degree in pharmacy, along with a minimum of 12 - 15 years of experience in regulatory affairs within the pharmaceutical industry for filing products in various regulatory agencies. You should have a strong understanding of regulatory guidelines and compliance requirements (such as FDA, EMA, etc.), excellent communication, organizational, and project management skills, and the ability to work collaboratively in a fast-paced environment. By joining Natural Biogenex Pvt. Ltd., you will have the opportunity to be a part of a leading API manufacturing company with cutting-edge technology and compliance standards. You will work in a state-of-the-art Quality Control Laboratory with global regulatory standards, contribute to regulatory audits and pharmaceutical quality excellence, and benefit from competitive salary and professional development opportunities.,

Key Responsibilities: Pick up parcels / documents from specified client locations Ensure timely and safe delivery of documents to clients / business locations.Submit visa applications to the relevant embassy or visa processing center as per the guidelines of the seniorsEnsure timely and proper submission as per standard procedures.Plan the schedules beforehand to avoid last minute hassle Communicate politely and professionally with clients / submission counters Ensure accurate labeling,packaging of the documents for the courier Handling courier documents with care and ensuring safe, undamaged delivery.Submission of the courier documents on a timely basisSupport inventory management by updating stock levels of stationary materials, required materials Handle basic queries or direct them to appropriate support staff.Maintain accurate records of deliveries and collections.Submit daily reports to the senior authorities Provide administrative support to senior administrative staffEnsure the vehicle is well-maintained, clean, fueled and report any issues or damages immediately.Adhere to traffic rules and company safety guidelines.Ensure the office premises are clean, organized, and properly maintained. Assisting the office teammates for scanning, printing or any other day to day work Any other work assigned by the organization on a timely basis Good verbal and written communication skills Ability to manage multiple client cases with attention to detail Problem-solving mindset with a focus on customer satisfaction Team player with the ability to work independently when needed Willingness to learn, adapt, and grow within a fast-paced environment

Key Responsibilities:Pick up parcels / documents from specified client locations Ensure timely and safe delivery of documents to clients / business locations.Submit visa applications to the relevant embassy or visa processing center as per the guidelines of the seniorsEnsure timely and proper submission as per standard procedures.Plan the schedules beforehand to avoid last minute hassle Communicate politely and professionally with clients / submission counters Ensure accurate labeling,packaging of the documents for the courier Handling courier documents with care and ensuring safe, undamaged delivery.Submission of the courier documents on a timely basisSupport inventory management by updating stock levels of stationary materials, required materials Handle basic queries or direct them to appropriate support staff.Maintain accurate records of deliveries and collections.Submit daily reports to the senior authoritiesProvide administrative support to senior administrative staffEnsure the vehicle is well-maintained, clean, fueled and report any issues or damages immediately.Adhere to traffic rules and company safety guidelines.Ensure the office premises are clean, organized, and properly maintained. Assisting the office teammates for scanning, printing or any other day to day work Any other work assigned by the organization on a timely basis Good verbal and written communication skills Ability to manage multiple client cases with attention to detail Problem-solving mindset with a focus on customer satisfaction Team player with the ability to work independently when needed Willingness to learn, adapt, and grow within a fast-paced environment