84 Regulatory Submissions Jobs - Page 2

#Hiring Regulatory Affairs Manager for one of the reputed MNC into Healthcare industry. Position Title: Regulatory Affairs Manager Location: Gurugram About Role:- The Regulatory Affairs Manager will be responsible for managing the regulatory strategy and ensuring the compliance of medical devices/IVD with applicable regulations. The candidate should have relevant years of experience in Regulatory Affairs. Preferably, complete knowledge of Indian Regulatory Requirements with in-depth understanding of D&C Act, MDR 2017& BIS. This role involves working closely with cross functional team. The manager will monitor regulatory changes, support product submissions, and ensure timely approvals to maintain product marketability in India. Key Accountabilities:- Provide Regulatory Support for timely new product launches. Well versed with filing application of Import Registration/Import license/Test License on SUGAM portal and NSWS & BIS Regulations & Certification. Stay abreast of regulatory procedures and changes in regulatory climate. Responsible for managing BIS application and submission procedures To review Medical Device dossier and technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents and take appropriate actions to obtain regulatory approvals as planned. Address queries from CDSCO/NSWS on submitted applications, provide regulatory support and assist in preparing a response to regulatory authoritys questions within assigned timelines. Responsible for managing modifications to a device after it has received regulatory approval. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. Timely tracking and reconciliation of routine submissions/activities/Query response Post-Market Surveillance: Manage post-market surveillance activities, including adverse event reporting, field safety corrective actions, and vigilance reporting. Minimum Knowledge & Experience required for the position: Bachelor's/ Masters degree in a relevant field, such as life sciences, or regulatory affairs. Around 5+ years of relevant experience in Healthcare Industry (Medical Devices/IVDs) in Regulatory Affairs (MNCs) is desirable. Skills & Capabilities: Hands-on experience with the NSWS/ SUGAM portal and CDSCO online submission process. Strong understanding of Indian regulatory frameworks including CDSCO & BIS. Attention to detail and critical thinking skills Ability to work collaboratively with cross-functional teams. Note:- Looking Male candidate with decent exposure into RA role with reputed MNC's. If above role matches with your experience & aspirations than share CV to: recruit.corp12@apexservices.in

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions to FDA and other global health authorities. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Maintain accurate records of all regulatory correspondence, reports, and audit findings. Ensure compliance with regulatory guidelines and requirements by reviewing documentation and conducting internal audits. Provide support during regulatory audits by gathering necessary information and preparing responses. Desired Candidate Profile 1-4 years of experience in Regulatory Affairs or related field (pharmaceutical industry). Bachelor's degree in Pharmacy (B.Pharma) or Science (B.Sc), preferably in a relevant specialization. Strong understanding of FDA regulations, regulatory operations, compliance, submissions, documentation, guidelines, issues, reports.

Regulatory Affairs Manager in Clinical Research @ Vimta Labs Ltd, Hyd Experience: 8-12 years of Regulatory Affairs experience in Clinical Research Industry. CTC: Based on their current CTC. Job Description Regulatory Affairs Manager Primary Responsibilities: 1.. Manage the activities of Regulatory Affairs for clinical research and ensure the implementation of effective regulatory strategies. 2. CDSCO, CBN and NCB getting approvals as required for Vimta. 2. Provide regulatory input to strategic decision making; including prioritization, and external communications 3. Provide regulatory input to in-licensing evaluations and due diligence activities 4. Provide advice about regulations to manufacturers/scientists 5. Coordinate successful submissions and approval of all applications 6. Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil applicable regulatory and quality standards. 7. Plan, undertake and manage regulatory inspections 8. Keep up to date with national and international guidelines and customer practices 9. Develop and establish standard operating procedures that convey the best practices in the company 10. Collect, collate, and evaluate scientific data from a range of source. 11. Monitor and set timelines for licence variations and renewal approvals 12. Ensures that Good Clinical Practices (GCP) are followed. 13.Responding to any quality & regulatory issues related to clinical department and taking relevant corrective and preventive actions Secondary Responsibilities: 1. Ensure Quality Control review of protocols, ICF, CRF protocol amendments, Clinical Trial Reports, Investigator Brochures and regulatory submission documents. 2. Interpretation of data. 3. Preparation and Review of Clinical Study Report Interested candidates can share their resumes to keerthana.rojanala@vimta.com Contact: Keerthana

The Senior Associate, Global Submission Management – Americas, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for US, Canada and South America

Manager - International Regulatory Lead Role NameManager – International Regulatory Lead (IRL) Department NameInternational Regulatory Team, Global Regulatory Affairs Role GCF5A ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to - optimize product development and regulatory approvals in International countries - develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience. Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality, and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing and/or over seeing preparation of submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post-market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC and/or Device submissions and related communications in the document management system Initiate and maintain CMC product and/or Device timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Doctorate degree OR Master’s degree and 5 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 7 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience managing or hovering staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Experience in IVD, Device or Combination Product regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

We are seeking a highly motivated Fresher Clinical Data Manager to join our clinical data management team. In this role, you will assist in managing, cleaning, and validating clinical trial data, ensuring data quality and compliance with regulatory stndards. This is an exciting opportunity for someone looking to start their career in clinical data management and gain exposure to the clinical research process. Manage and analyze clinical trial data, ensure data accuracy, and support regulatory submissions. Work mode Remote/Hybrid

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions