Regulatory Writing and Submission Scientist

**Industry** Pharmaceuticals, Cosmetics, Medical Devices, Food Supplement, Labeling and Scientific Communications **Position** Full Time, Permanent **Division** Pubrica Brand **Reports to**: Pubrica Business Head **About Company** Guires Group is a renowned global provider of services in advanced Contract Research, Data Science, Development, Pilot...

General Accountability Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files. **Responsibilities**: 1. Write, analyze, and edit...

**Key Responsibilities**: - **Regulatory Compliance**: Ensure compliance with ISO 13485, EU MDR 2017/745, US-FDA, CDSCO, and other applicable international standards for medical devices. - **Submissions and Approvals**: Prepare, review, and submit regulatory documentation, including 510(k) and IMDR submissions, to regulatory authorities such as US-FDA,...

Regulatory - ChemistLocation: Chennai, IndiaRequired Language: EnglishEmployment Type: Full-TimeSeniority Level: AssociateTravel Mode: ModerateAbout Us:Buckman is a privately held, global specialty chemical company with headquarters in Memphis, TN, USA, committed to safeguarding the environment, maintaining safety in the workplace, and promoting sustainable...

Regulatory - ChemistLocation: Chennai, IndiaRequired Language: EnglishEmployment Type: Full-TimeSeniority Level: AssociateTravel Mode: ModerateAbout Us:Buckman is a privately held, global specialty chemical company with headquarters in Memphis, TN, USA, committed to safeguarding the environment, maintaining safety in the workplace, and promoting sustainable...

Regulatory - Chemist Location: Chennai, India Required Language: English Employment Type: Full-Time Seniority Level: Associate Travel Mode: Moderate About Us: Buckman is a privately held, global specialty chemical company with headquarters in Memphis, TN, USA, committed to safeguarding the environment, maintaining safety in the workplace, and...

**Industry** Pharmaceuticals, Cosmetics, Medical Devices, Food Supplement, Labeling and Scientific Communications **Position** Full Time, Permanent **Division** Pubrica Brand **Reports to**: Pubrica Business Head **About Company** Guires Group is a renowned global provider of services in advanced Contract Research, Data Science, Development, Pilot...

Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...

Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...

**Regulator Chemist** **Location**:Chennai, India **Required Language**:English **Employment Type**:Full-Time **Seniority** **Level**:Associate** **Travel** Mode**:Moderate ***: **About Us**: Buckman is a privately held, global specialty chemical company with headquarters in Memphis, TN, USA, committed to safeguarding the environment, maintaining...

**Job highlights** - Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science. Qualification: M Sc Life Science/ BTech Medical / B Pharm/ M Pharm. - Minimum of 2-3 years of experience in regulatory affairs Healthcare industry, with specific experience in USFDA / 510K submission and MDSAP Audit preparation **Job description** This is a...

Our people work differently depending on their jobs and needs. From hybrid working to flexible hours, we have plenty of options that help our people to thrive. This role is based in India and as such all normal working days must be carried out in India. Join us as a Regulatory Control Associate - This is a great opportunity to join our business and play a...

ROLE SUMMARY ROLE RESPONSIBILITIES - Auditing (verifying) of data and information against source documents and data systems for completeness and accuracy. Perform data verification of Biologics License Applications, Investigational New Drug Applications and other regulatory documents in compliance with Pfizer internal Standard Operating Procedures. Perform...

Job Purpose With merger of Lakshmi Vilas Bank and introduction of various strategic initiatives with automations being launched, the portfolio is expected to grow and along with it, the reporting requirements and complexities are expected to increase, which would demand a junior maker for the standard regulatory reports and day-to day BAU activities & to...

Job Purpose With merger of Lakshmi Vilas Bank and introduction of various strategic initiatives with automations being launched, the portfolio is expected to grow and along with it, the reporting requirements and complexities are expected to increase, which would demand a junior maker for the standard regulatory reports and day-to day BAU activities & to...

Job Purpose With merger of Lakshmi Vilas Bank and introduction of various strategic initiatives with automations being launched, the portfolio is expected to grow and along with it, the reporting requirements and complexities are expected to increase, which would demand a junior maker for the standard regulatory reports and day-to day BAU activities & to...

We are in the process of hiring Regulatory Affairs **Job Title**: Regulatory Affairs Executive **Key Responsibilities**: **Qualifications**: Bachelor Degree in a related field such as Biomedical engineering, Mechanical engineering with minimum of 2 years’ progressive Regulatory affairs experience in medical device & quality...

Job Summary The Regulatory Affairs Specialist is responsible for ensuring compliance with all applicable regulations governing the development, manufacturing, and distribution of the company's products. This role involves collaborating with internal teams and regulatory agencies to facilitate product registrations, approvals, and adherence to quality...

Job PurposeWith merger of Lakshmi Vilas Bank and introduction of various strategic initiatives with automations being launched, the portfolio is expected to grow and along with it, the reporting requirements and complexities are expected to increase, which would demand a junior maker for the standard regulatory reports and day-to day BAU activities & to...

Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changes globally in collaboration with the CMC GRS.- Global regulatory strategy development in collaboration with the CMC GRS.- Liaise with Pfizer Global Supply and other support functions as needed.- Use of regulatory systems and management of CMC documentation...