910 Usfda Jobs

Job Title: Regulatory Affairs Head / Manager API Division Department: Regulatory Affairs Industry: Pharmaceuticals Active Pharmaceutical Ingredients (API) Location: Andheri East Experience Required: 815 Years (API Regulatory Affairs) Qualification: M.Pharm / B.Pharm / M.Sc (Chemistry / Pharmaceutical Sciences) Salary Up to 1Lakhs per Month Job Purpose: To lead and manage the Regulatory Affairs department for API products, ensuring compliance with global regulatory requirements and facilitating product registrations, dossier submissions, and approvals across domestic and international markets. Key Responsibilities: Regulatory Strategy & Compliance: Develop and implement regulatory strategies ...

Job Title: Regulatory Affairs Head / Manager API Division Department: Regulatory Affairs Industry: Pharmaceuticals Active Pharmaceutical Ingredients (API) Location: Andheri East Experience Required: 815 Years (API Regulatory Affairs) Qualification: M.Pharm / B.Pharm / M.Sc (Chemistry / Pharmaceutical Sciences) Salary Up to 1Lakhs per Month Job Purpose: To lead and manage the Regulatory Affairs department for API products, ensuring compliance with global regulatory requirements and facilitating product registrations, dossier submissions, and approvals across domestic and international markets. Key Responsibilities: Regulatory Strategy & Compliance: Develop and implement regulatory strategies ...

Role Overview: As a Manager- Regulatory Affairs-International, your primary purpose will be to manage and oversee the preparation, review, and timely submission of regulatory dossiers in CTD and ACTD formats for international markets. You will ensure ongoing regulatory compliance and support product lifecycle management across ROW and emerging markets. Key Responsibilities: - Prepare and review Common Technical Document (CTD) and ASEAN Common Technical Document (ACTD) dossiers. - Coordinate with manufacturing sites and R&D to gather necessary data and documents for regulatory submissions. - Ensure plant compliance with regulatory requirements and facilitate timely implementation of changes. ...

We are looking for a skilled Business Development Executive to join our team at P.S International HR Consultants. The ideal candidate will have 6 to 11 years of experience in sales and marketing, with a strong background in driving business growth. Roles and Responsibility Develop and implement effective sales strategies to achieve business objectives. Build and maintain strong relationships with clients and identify new business opportunities. Conduct market research to stay updated on industry trends and competitor activity. Collaborate with cross-functional teams to drive business development initiatives. Analyze sales data and performance metrics to inform business decisions. Identify an...

Identification of areas for improvement within operations and provide recommendations for change through the quality assurance process. Development and implementation of quality control procedures and controls to mitigate risks and maintain efficient operations. Collaboration with teams across the bank to develop quality improvement guidelines, initiatives, objectives, and action plans to monitor performance, improve business areas and govern processes. Development of reports and presentations on quality control performance and communicate findings to internal senior stakeholders. Monitoring of customer-facing colleagues performance, and evaluating their performance through reviews, quality ...

1. Project & Engineering Management 2. Maintenance, Reliability & Calibration 3. Energy, Safety & Environmental Compliance 4. People Leadership & Capability Development 5. Digitalization, Operational Excellence & Continuous Improvement Required Candidate profile • Bachelor’s or Master’s degree in Mechanical, Electrical, Instrumentation, or Automation Engineering (B.E./M.E., B.Tech/M.Tech). • 16+ years of experience in pharmaceutical

Skills Required: Graduate / PG in management With a minimum of 4 7 years of experience in managing the Admin function. Must have hands on experience into Advance Excel Key Responsibilities Making MIS Reports of collated data Meticulously working on the data collated from various sources of department and preparing comprehensive reports Ensuring the precision of the reports Preparing Delivery Files Extensive work on Excel Preparing necessary dashboards for day to day operations Monitor & analyses data for business trends & prepare monthly revenue & collection report Provide cross functional quality oversight from a compliance perspective fo testing and disposition, quality investigations, val...

Overview We are seeking a highly organized, proactive, and detail-oriented Executive Assistant to support our Senior Vice President (SVP)/ Vice President (VP). This role requires a high level of professionalism, discretion, and the ability to anticipate needs while managing a wide range of administrative and executive support tasks in a fast-paced environment. Responsibilities Manage and optimize the SVP/VPs calendar, scheduling meetings, appointments, and travel arrangements. Prepare, review, and organize correspondence and other confidential documents. Coordinate internal and external meetings, including logistics, agendas, and follow-ups. Serve as a liaison between the SVP and internal/ex...

POSITION DESCRIPTION: The Quality and Regulatory Affairs (QARA) Specialist will provide leadership in the quality and regulatory affairs function to understand regulatory requirements of medical devices, create relevant documentation and providing consultancy as an expert in regulatory affairs for IZiel clients The RA specialist will work with clients in India and globally across USA and Europe to provide solutions for getting approvals for their products for launch in the Europe and USA The candidate will require to go through extensive training in various country specific regulations as needed to keep themselves up-to-date with the latest and greatest updates as well as represent IZiel at ...

Job Description - Key Accountabilities (1/6) Ensure smooth operations of all administrative and FM responsibilities related to the Sales & Marketing Offices based in South India. Supervise HK manpower supply, attendance, grooming and timely deputation to the department. Ensure FM supports to be extended as per SOPs and followed it regular basis, Ensure all HK/Garden/Linen management staff follow guidelines and trained for the respective work. Support to India Marketing team to conduct meetings & employee engagements etc. Look after lease of building, rent and maintenance of the office area. Ensure smooth operations of all administrative and FM responsibilities Plant (Bommasandra) To manage c...

- Develop & Execute regulatory strategies - Stay updated on evolving global regulatory requirements & ensure products comply with international standards - Collaboration with Cross functional teams including R&D, QA, Clinical developments. Required Candidate profile - Strong leadership & management skills, including experience leading cross functional teams - Proven track record of successful regulatory submissions & approvals

Qualification & Experience: Qualification: M.Sc. Chemistry. Experience: 16- 25 years in Quality Assurance within an API or Bulk Drug Manufacturing environment. Must have prior exposure to USFDA and other international audits . Role & responsibilities Lead In-Process Quality Assurance (IPQA) activities across production and packaging areas. Ensure compliance with USFDA, WHO-GMP, MHRA, and other international regulatory requirements . Prepare, review, and approve QA documents SOPs, batch records, deviations, CAPA, and change controls. Plan and coordinate regulatory and customer audits , including audit readiness and follow-up actions. Conduct supplier audits and evaluate vendor quality systems...

JOB DETAILS Candidates should review and prepare regulatory submissions, including new ANDA filings, amendments and Annual reports to the ANDA. Review of DMF Manages USFDA registration activities FUNCTIONAL AREA Pharma Jobs Consultancy in Chennai, Pharma Jobs Consultancy near me, Pharma Jobs, Top, Best, Jobs Consultancy in Chennai, regulatory affairs jobs in chennai, regulatory affairs jobs in tamilnadu, pharma jobs in chennai

Role : Design Quality SME Location : Pune Experience: 8+ Years Working days : 5 days work form Office. Degree in mechanical engineering,electrical engineering,applied sciences or a related discipline; 8+ years of professional experience in medical device regulatory Quality systems EU MDR,US FDA 510(K)and closely working R&D,Regulatory Affairs organizations Strong proven experience in simplifying/reviewing DHFs,Design requirements,IFUs,Risk management,V&V activities etc . Expertise in interpreting &implementing various medical device standards and guidance's,such as IEC 60601-1,ISO 14971-1,IEC 62366-1,ISO10993-1,and MEDDEV 2.7/4. Experience with systems for quality management,product developm...

Skills: FLUENT ENGLISH, Passionate About Work, good communication, Interpersonal Skills, teaching, english,. Company Overview. Touchstone Educationals LLP is a leading IELTS Education Institute with a network of branches across Punjab, Haryana, and Rajasthan. Job Overview. Touchstone Educationals LLP is hiring a Counselor to join our team in Khanna, Punjab, India. As a leading IELTS Education Institute, Touchstone has been providing expert services for those seeking to study in Canada and Australia for over two decades. The Counselor will be responsible for providing personalized guidance and support to students, helping them navigate the study abroad process. Qualifications And Skills. Bach...

Skills: direct sales, communication skills, ielts, sales, target achiever, sales target,. Job Overview. Touchstone Educationals LLP is seeking a Counselor for our Ajnala and Patti branches in Punjab, India. As a counselor, you will be responsible for providing expert guidance and personalized services to individuals seeking to study in Canada and Australia. This is a full-time position suitable for candidates with less than 1 year of experience. Qualifications And Skills. Bachelor's degree in any field. Excellent interpersonal and communication skills. Strong counseling and problem-solving abilities. Ability to empathize and understand the needs of students. Show more Show less

Skills: sales, Target Orientation, Interpersonal Communication, fluent english, Communication, Customer Relationship Management (CRM),. Company Overview. Touchstone Educationals LLP is a leading IELTS Education Institute with a network of branches across Punjab, Haryana, and Rajasthan. With over two decades of experience, we have been providing expert and personalized services to students. Job Overview. Touchstone Educationals LLP is looking for an Admission Counsellor to join our team. As an Admission Counsellor, you will be responsible for providing expert guidance and support to students who are seeking to study in Canada and Australia. The ideal candidate should have a strong understandi...

Skills: sales, direct sales, target oriented, good communication skills, ielts, fluent english,. Company Overview. Touchstone Educationals LLP is a leading IELTS Education Institute with a network of branches across Punjab, Haryana, and Rajasthan. With over two decades of experience, we have been providing expert and personalized services to students aspiring to study in Canada and Australia. Job Overview. We are hiring a Counselor for our branch in Chandigarh, India. As a Counselor, you will be responsible for providing expert guidance and personalized services to students who are seeking to study in Canada and Australia. This is a full-time position suited for fresher candidates with less ...

Skills: sales, education, ielts, target, communication, counseling,. Company Overview. Touchstone Educationals LLP is a leading visa and immigration consultancy firm with a network of branches across Punjab and Haryana. We have been providing expert and personalized services for those seeking to study in Canada and Australia for over two decades. With over 1001-5000 employees, Touchstone Educationals LLP is dedicated to helping students achieve their dreams of international education. Job Overview. Touchstone Educationals LLP is seeking a highly motivated and dynamic Sales Counselor (Females) to join our team. As a Sales Counselor, you will be responsible for IELTS counselling. We are lookin...

Skills: direct sales, communication skills, ielts, sales, target achiever, sales target,. Company Overview. Touchstone Educationals LLP is a leading IELTS Education Institute with a network of branches across Punjab, Haryana, and Rajasthan. We have been providing expert and personalized services for those seeking to study in Canada and Australia for over two decades. With over 1001-5000 employees, we are dedicated to helping students achieve their educational goals. Job Overview. Touchstone Educationals LLP is seeking a Counselor for our Ajnala and Patti branches in Punjab, India. As a counselor, you will be responsible for providing expert guidance and personalized services to individuals s...

Conduct thorough examinations and diagnoses to determine the best course of treatment.Develop and implement effective treatment plans for patients with various medical conditions. Required Candidate profile MS degree in a relevant field. Strong knowledge of ENT surgery procedures and techniques. Excellent communication and interpersonal skills.

Introduction: Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research and Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Biosys Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research D...

Perform surgical procedures related to the senses, including hearing and balance disorders.Conduct thorough examinations and diagnoses to determine the best course of treatment. Required Candidate profile Minimum 2 years of experience as an ENT surgeon in a hospital setting. Strong knowledge of surgical techniques and procedures related to the senses. Excellent communication and interpersonal skills

Job Summary: We are seeking a skilled and motivated Research Scientist to join our Formulation & Development (F&D) Oral Solid Dosage (OSD) team. The ideal candidate will be responsible for the design, development, and optimization of oral solid dosage forms (tablets, capsules, etc.) from concept to commercial scale. The role involves conducting pre-formulation studies, formulation trials, process optimization, and technology transfer to manufacturing sites while ensuring compliance with regulatory and quality standards. Key Responsibilities: Design and develop robust formulations for oral solid dosage (OSD) products, including tablets, capsules, and modified-release systems. Conduct pre-form...

Role & responsibilities Manager technical is the In-charge of Analytical Division. He/She shall report to the SBU-head about all the activities in the Analytical Division. He/She shall look after all the operations of the Division under the guidance/ supervision of SBU-Head. He/She shall be responsible for the standardization and validation of the test methods. He/She shall be responsible for ensuring the availability of the reference material / working reference standard. He/She shall be responsible for assigning the jobs to the analyst as per their calibre. He/She shall be responsible for checking the calculation part and reporting of the results before sending for authorized signatory. He...