378 Ctd Jobs

- Looking for RA Deputy Manager - for US Market and RA - Asst. Manager - for ROW Market - Only from Pharmceutical Industry

Overview At Boeing, we believe creativity and innovation thrives when every employee is trusted, empowered, and has the flexibility to choose, grow, learn, and explore. We offer variable arrangements depending upon business and customer needs, and professional pursuits that offer greater flexibility in the way our people work. We also believe that collaboration, frequent team engagements, and face-to-face meetings bring together different perspectives and thoughts enabling every voice to be heard and every perspective to be respected. No matter where or how our teammates work, we are committed to positively shaping peoples careers and being thoughtful about employee wellbeing. Boeing India P...

Job Criteria: B.Pharm or M.Pharm qualification having experience between 7 - 15 yrs. with dossier filling experience in MEXICO or South East Asian Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skill Job Responsibility: Compilation and review of product license applications, variations, and renewals for Mexico country as per regulatory requirements respectively with minimal supervision Manages electronic documents and creates electronic submissions in CTD format. Preparation and review of responses to authority questions during registration and product lifecycle. Keep track of assigned projects and follow-ups t...

Roles and Responsibilities : Maintain client relations to build excellent reputation for service and produce repeat business. Interact regularly with top ten accounts related to weekly selling, deliveries and stock availability. Maintaining contact with existing clients to ensure that they are satisfied with their services Building relationships with existing clients to ensure repeat business and new business opportunities Managing existing customer accounts by ensuring that existing customers remain satisfied with company products and services. Developing and implementing effective account plans to retain existing customers. Identifying customer needs and communicating how company products ...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Document Management Systems (DMS) Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will engage in the design, construction, and configuration of applications tailored to fulfill specific business processes and application requirements. Your typical day will involve collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications are optimize...

About The Role 11137 To drive sales and ensure business targets are achieved o Aggressively drive the sales numbers and achieve the business targets for Retail loan products and through cross selling while continuing to enhance and upgrade the client relationships. o Retain and expand the company's base of customers for retail loan product so as to ensure repeat business or referrals o Maximize sales through a network and relationships to ensure strong business o Develop and maintain strong liaisons with the clients for repeat business or referrals. o Ensure the files are processed from login stage to disbursement and liaise with internal departments (Operations and Credit) for completion. o...

We are looking for a skilled ENT Surgeon with 28 years of experience to join our team. The ideal candidate will have a strong background in the field and excellent surgical skills. Roles and Responsibility Perform complex surgeries on patients with various ear, nose, and throat conditions. Conduct thorough examinations and diagnoses to determine the best course of treatment. Develop and implement effective treatment plans for patients. Collaborate with other healthcare professionals to provide comprehensive care. Stay updated with the latest advancements and technologies in the field of ENT surgery. Provide guidance and support to junior medical staff members. Job Requirements Minimum 28 yea...

We are looking for a skilled ENT Surgeon with 28 years of experience to join our team. The ideal candidate will have a strong background in the field and excellent surgical skills. Roles and Responsibility Perform complex surgeries on patients with various ear, nose, and throat conditions. Conduct thorough examinations and diagnoses to determine the best course of treatment. Develop and implement effective treatment plans for patients. Collaborate with other healthcare professionals to provide comprehensive care. Stay updated with the latest advancements and technologies in the field of ENT surgery. Provide guidance and support to junior medical staff members. Job Requirements Minimum 28 yea...

We are looking for a skilled ENT Surgeon with 28 years of experience to join our team. The ideal candidate will have a strong background in the field and excellent surgical skills. Roles and Responsibility Perform complex surgeries on patients with various ear, nose, and throat conditions. Conduct thorough examinations and diagnoses to determine the best course of treatment. Develop and implement effective treatment plans for patients. Collaborate with other healthcare professionals to provide comprehensive care. Stay updated with the latest advancements and technologies in the field of ENT surgery. Provide guidance and support to junior medical staff members. Job Requirements Minimum 28 yea...

We are looking for a skilled ENT Surgeon with 28 years of experience to join our team. The ideal candidate will have a strong background in the field and excellent surgical skills. Roles and Responsibility Perform complex surgeries on patients with various ear, nose, and throat conditions. Conduct thorough examinations and diagnoses to determine the best course of treatment. Develop and implement effective treatment plans for patients. Collaborate with other healthcare professionals to provide comprehensive care. Stay updated with the latest advancements and technologies in the field of ENT surgery. Provide guidance and support to junior medical staff members. Job Requirements Minimum 28 yea...

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

We are seeking an experienced Regulatory Affairs professional to support and manage the regulatory lifecycle of oral solid dosage (OSD) products across key global markets, including the EU, USA, and RoW.

Our Ideal Candidate: Our ideal candidate will typically be expected to demonstrate the following attributes: Good technical knowledge in Oracle Cloud Infrastructure Knowledge & working experience in ExaCS Understanding of Technical architecture landscape Should have a strong customer facing skills Ability to multitask, maintain composure in high-stress/high-visibility situations and change priority as needed to accommodate very dynamic business. Excellent team player, willing to learn new technologies Strong organization skills, detail oriented & communication skills. . University degree, with post graduate technical or management qualifications or other relevant experience. OCI Certified / ...

Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna. Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement. To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement. Responsible for prepare and review Drug Master File as per respective reulatory agency guidline. Responsible for ensuring that DMF submitting regulatory documentation, maintaning compliance and advising on regulatory strategies. To ensure that Drug Master File (DMF) meet to current respective regulatory agency guideline. Responsible for prepare Drug Master File (DMF) Defi...

Total Experience Required: Minimum 4 years in the Core Regulatory Affairs Department Qualification: B.Pharma/ M. Pharma Minimum 4 years of experience in the compilation and preparation of dossiers for semi-regulated and regulated markets. Analyze and respond to inquiries from regulatory agencies and customers worldwide, ensuring timely submissions within set deadlines. Maintain a well-organized and up-to-date regulatory filing system, including databases and chronologies, for easy tracking of changes made to documents submitted to agencies or partners. Proactively update existing internal regulatory guidelines and develop new ones as needed to ensure alignment with current requirements. Cont...

We're Hiring: Regulatory Affairs CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or biotech setting. Strong experience in US FDA regulations and ICH guidelines. Experience in handling pre- and post-approval submissions is required Interested candidates can share their resumes on sheetal.na@peoplefy.com

Key Responsibilities: Develop, implement, and maintain robust financial crime prevention policies and procedures, including anti-money laundering (AML), fraud, sanctions compliance, and counter-terrorism financing (CTF). Lead and manage financial crime risk assessments and due diligence processes. Oversee investigations related to suspicious activities, ensuring timely escalation and resolution. Ensure compliance with applicable laws, regulations, and industry standards. Coordinate with internal departments and external regulators on compliance issues. Monitor and report on regulatory changes and implement necessary adjustments. Provide training and awareness programs on financial crime and ...

Role Description: As the Finance Head, the candidate will play a pivotal role in overseeing the financial health and strategy of the Company. The candidate will be responsible for managing the finance department, implementing financial policies, and ensuring compliance with regulations while contributing to the company's overall growth and profitability. As the Head of Process Excellence, the candidate will be responsible for driving standardization of processes across the organization, by strategically leveraging technology and optimizing processes to ensure operational efficiency, and create system based controls to build the platform for scale. In this process he will play a pivotal role ...

Johnson Controls is looking for Sr. Analyst - RTR EMEA to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

1. Drug Regulatory Affairs - Job description Prepare CTD, ACTD Dossiers and file regulatory submissions Perform assessments of new or revised products Manage complaint documentation (including investigation and closure) Respond to inquiries from regulatory bodies Should be technically well versed with requirements for Medicines with fare knowledge about Food supplement, medicines To Coordinate with relevant department for arranging documents To prepare / compile dossier for allocated products / countries To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc To coordinate with courier agency for dispatches of dossier /samples To make timel...

Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Manage and supervise a team of professionals to ensure efficient operations. Analyze operational data to identify areas for improvement and optimize processes. Coordinate with various departments to ensure seamless operations and resolve issues. Implement and maintain quality control measures to ensure high standards. Identify and mitigate risks to ensure compliance with regulatory requirements. Job Requirements Proven experience in operations management with a minimum of 5 years of experience. Strong knowledge of operational principles and practices. Excellent leadership, communication, and...

1. Prepare, review & submission of quality regulatory dossiers in CTD/eCTD format for Europe & other domestic markets. 2. Support product development, registration, & lifecycle management in Europe 3. Manage Regulatory Compliance & Approvals Required Candidate profile 1. Minimum 4 years of exp in Formulation OSD 2. Willing to work in Chennai 3.Strong expertise in EU, EMA, MHRA & other international regulatory framework 4. Exposure in domestic regulatory market

Roles and Responsibility Develop and implement operational strategies to achieve business objectives. Manage and supervise a team of professionals to ensure efficient operations. Analyze operational data to identify areas for improvement and optimize processes. Collaborate with cross-functional teams to align with organizational goals. Ensure compliance with regulatory requirements and industry standards. Foster a culture of continuous improvement and excellence within the team. Job Requirements Proven experience in operations management with a minimum of 8 years of experience. Strong leadership and management skills, with the ability to motivate and inspire teams. Excellent analytical and p...

Role & responsibilities Exploration of updated guidelines needed for dossier compilation for ROW market/ Regulated Market. Preparation, compilation, review, and submission of Pharmaceutical Dossiers to emerging market as per International Conference on Harmonization (ICH) and country specific guidelines in Common Technical Document (CTD), Asian Common Technical Document (ACTD) and regional format. Internal communication & follow-ups with various departments for various documents. To arrange and send samples for registration purpose to various countries. Review at all quality data received from various departments before using in dossiers and technical packages. Preparation and submission of ...

As a Jr. Officer to Sr. Officer at our company, you will be responsible for the following: - Preparation of dossiers and documents in compliance with CTD, ACTD, and country-specific guidelines. - Reviewing dossiers, DMF, and technical documents. - Addressing queries raised by regulatory authorities. Qualification Required: - Must have an M.Pharm degree. The work location for this position is in Jarod, Vadodara, Gujarat. Additionally, we offer benefits such as health insurance, leave encashment, life insurance, paid sick time, and provident fund. Please note that this position requires a long-term association agreement with an incentive scheme for 2-3 years.,