9 Submission Management Jobs

As a Manager/Sr Manager Regulatory Affairs Emerging Markets at UMEDICA, you will play a crucial role in the Regulatory Affairs department at our R&D center in Turbhe Navi Mumbai. Your primary responsibility will be to develop and implement strategic plans for regulatory submissions and ensure ongoing compliance. Your role will involve overseeing the preparation and submission of regulatory applications and amendments to relevant agencies. You will also serve as the primary point of contact with customers/regulatory authorities, representing the company. Key Responsibilities: - Develop and implement strategic plans for regulatory submissions and ongoing compliance. - Oversee the preparation a...

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 a...

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 re...

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 ...

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...

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 tec...

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 heal...

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 updati...

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 updatin...