Sr. Executive

2 weeks ago

Mumbai, Maharashtra, India Lifelancer Full time

Job Title: Sr. Executive -Regulatory Affairs.

Job Location: Mumbai, Maharashtra, India

Job Location Type: On-site

Job Contract Type: Full-time

Job Seniority Level: Associate

Skills:
Regulatory Compliance, FDA Regulations, Quality Assurance, Documentation Management, Risk Assessment, Communication Skills, Project Management, Regulatory Operations,

Position: Sr. Executive -Regulatory Affairs.

Location: Andheri, Mumbai.

Salary: Up to 7.7lpa

Interview Mode: In person

Qualification: B. Pharm./M. Pharm. (Experienced preferred).

The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with experience in FDA related activities. This profile will ensure timely and robust functional/crossfunctional coordination (R&D, QC, Marketing, Legal, Production, etc.), transparent execution and implementation of regulatory affairs and safety processes.

Local Regulatory Function (Licensing)
  • Prepare registration dossier for procuring certificates/license from local FDA, DCGI and FSSAI. This would entail thorough familiarity with FDA, Sugam & FSSAI online portal, Drugs & Cosmetics Act and its various Schedules e.g. Sch Y, M, etc.
  • Confirm product formula and label acceptability, as well as the receipt of necessary licenses, prior to the release of product. o Co-ordinate with QC and R&D departments for technical documents (manufacturing documents like batch records, specifications, analytical methods, validation reports, and stability data) required to be incorporated in the registration dossiers.
  • Ensure timely renewal of drug and food licenses maintained by head office and also branch offices based at various states in the country.
  • Online application for obtaining test license for import purpose.
  • Maintain archival of all regulatory permissions. o Keep abreast of the updates pertaining to regulatory requirements and accordingly implement them.
  • Prepare responses to the legal & technical queries raised by the Regulatory authorities.

Compliance Of Packaging Modules
  • Formulate and implement statutory requirements pertaining to the artworks of the products (label, carton, package insert, patient information leaflet, etc.).
  • Review the artwork of all packaging material.
  • Prepare package insert as per New Drugs and Clinical Trials Rules 2019.

Pharmacovigilance
  • Provide high quality medical writing from planning and coordination of literature research.
  • Draft and review PSURs with focus on medical aspects of the products and safety sections.
  • Review of Risk Management Plans as per Regulatory requirement.
  • Good knowledge in assessing the risk-benefit of a product and identify any gaps in the aggregate documents.
  • Perform scientific review of aggregate reports / ICSRs produced by PV Associates.


Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

https://lifelancer.com/jobs/view/30e820f13b146cf923d4e317463df6a3

Apply on Lifelancer Platform

  • Sr. Sales Executive

    1 week ago

    Mumbai, Maharashtra, India Edifice Medical Technologies Full time

    Company Description Edifice Medical Technologies is a solutions provider for equipment and technology in hospital infrastructure, operating rooms, and surgery. They offer a range of integrated operating room solutions, surgical devices, and sterilization equipment from reputable international suppliers. Role Description This is a full-time on-site Sr. Sales...

  • Sr. Sales Executive

    7 days ago

    Mumbai, Maharashtra, India Edifice Medical Technologies Full time

    Company Description Edifice Medical Technologies is a solutions provider for equipment and technology in hospital infrastructure, operating rooms, and surgery. They offer a range of integrated operating room solutions, surgical devices, and sterilization equipment from reputable international suppliers. Role Description This is a full-time on-site Sr. Sales...

  • Sr. Sales Executive

    2 weeks ago

    Mumbai, Maharashtra, India Edifice Medical Technologies Full time

    Company DescriptionEdifice Medical Technologies is a solutions provider for equipment and technology in hospital infrastructure, operating rooms, and surgery. They offer a range of integrated operating room solutions, surgical devices, and sterilization equipment from reputable international suppliers.Role DescriptionThis is a full-time on-site Sr. Sales...

  • Sr. Sales Executive

    2 weeks ago

    Mumbai, Maharashtra, India Edifice Medical Technologies Full time

    Company DescriptionEdifice Medical Technologies is a solutions provider for equipment and technology in hospital infrastructure, operating rooms, and surgery. They offer a range of integrated operating room solutions, surgical devices, and sterilization equipment from reputable international suppliers.Role DescriptionThis is a full-time on-site Sr. Sales...

  • Sr. Sales Executive

    2 weeks ago

    Mumbai, Maharashtra, India Edifice Medical Technologies Full time

    Company DescriptionEdifice Medical Technologies is a solutions provider for equipment and technology in hospital infrastructure, operating rooms, and surgery. They offer a range of integrated operating room solutions, surgical devices, and sterilization equipment from reputable international suppliers.Role DescriptionThis is a full-time on-site Sr. Sales...

  • Executive/Sr. Executive

    1 day ago

    Mumbai, Maharashtra, India Associated Broadcasting Co. Pvt Ltd (TV9) Full time

    Job DescriptionCompany DescriptionPromoted by Associated Broadcasting Company Pvt Ltd (ABCL), TV9 Network is Indias No. 1 News Network, recognized for its free and fearless journalism aimed at empowering citizens. Launched in 2004 with TV9 Telugu, the network now includes channels in Kannada, Marathi, Gujarati, and the rapidly growing TV9 Bharatvarsh in...

  • Sr. Executive

    3 weeks ago

    Navi Mumbai, Maharashtra, India Teleperformance Global Services Private Limited Full time

    Job DescriptionWe are currently hiringDesignation- Sr. Executive / Executive Procurement Contract ManagementLocation- ThaneResponsible for managing all vendor contracts related to procurementDuties & Responsibilities- Drafting contract terms of agreement and pricing- Contract Signoff from all parties- MIS Reporting include weekly monthly MIS reports-...

  • Sr. Executive

    2 weeks ago

    Mumbai, Maharashtra, India ICCS Full time

    Position: IT Sr. Executive Location: Mumbai Experience: 1 - 3 Years Notice Period: Immediate - 15 Days Roles and Responsibilities Resolve system malfunctions, and provide technical information Installation, configuration Provide technical help Troubleshoot, monitor, and update the internal ticketing system for assigned tickets and assigned...

  • Executive (sr)

    7 days ago

    Mumbai, Maharashtra, India ASBS & CO. Full time

    xef x82 xb7 Basic understanding of bank products - Retail Liabilities Credit cards Retail Loans xef x82 xb7 BO complaints BO advisories along with all previous complaints of the same issue are to be analysed xef x82 xb7 Data Dump is to be extracted from CRM system xef x82 xb7 Using the customer ID all the past Service Requests SR of the same...

  • Sr. Executive

    3 days ago

    Mumbai, Maharashtra, India The Viral Fever Full time

    About The JobThe Viral Fever is a leading digital media company that creates engaging content for various platforms. We are seeking a highly skilled and experienced Sr. Executive to join our Content Planning team as a Sr. Executive - Media Planning.Key ResponsibilitiesThe successful candidate will be responsible for:Planning and executing media planning...

  • Sr. Executive

    1 week ago

    Mumbai, Maharashtra, India Lifelancer Full time

    Job Title: Sr. Executive -Regulatory Affairs. Job Location: Maharashtra Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Associate Skills:Regulatory Compliance, FDA Regulations, Quality Assurance, Documentation Management, Risk Assessment, Communication Skills, Project Management, Regulatory Operations,Position: Sr. Executive...

  • Sr. Executive

    2 weeks ago

    Mumbai, Maharashtra, India Lifelancer Full time

    Job Title: Sr. Executive -Regulatory Affairs. Job Location: Maharashtra Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Associate Skills:Regulatory Compliance, FDA Regulations, Quality Assurance, Documentation Management, Risk Assessment, Communication Skills, Project Management, Regulatory Operations,Position: Sr. Executive...

  • Assistant Manager/ Sr. Executive Procurement

    2 weeks ago

    Mumbai, Maharashtra, India Isprava Full time

    - Position : Assistant Manager – Procurement - Real Estate - Position : Sr. Executive – Procurement - Real Estate - (Interior Purchase Background preferred)We also have Walk-In-Interviews : for the above positions:Date : 10th/11th March 2025Contact Person : Mr. Pereira / Interview Time : 10am to 4pmVenue : 42A, Impression House, GD Ambekar Marg, Kohinoor...

  • Assistant Manager/ Sr. Executive Procurement

    1 week ago

    Mumbai, Maharashtra, India Isprava Full time

    Position : Assistant Manager – Procurement - Real Estate Position : Sr. Executive – Procurement - Real Estate ( Interior Purchase Background preferred)We also have Walk-In-Interviews :for the above positions: Date : 10th/11th March 2025 Contact Person : Mr. Pereira / Interview Time : 10am to 4pm Venue : 42A, Impression House, GD Ambekar Marg, Kohinoor...

  • Assistant Manager/ Sr. Executive Procurement

    2 weeks ago

    Mumbai, Maharashtra, India Isprava Full time

    Position : Assistant Manager – Procurement - Real EstatePosition : Sr. Executive – Procurement - Real Estate( Interior Purchase Background preferred)We also have Walk-In-Interviews : for the above positions:Date : 10th/11th March 2025Contact Person : Mr. Pereira / Interview Time : 10am to 4pmVenue : 42A, Impression House, GD Ambekar Marg, Kohinoor...

  • Assistant Manager/ Sr. Executive Procurement

    2 weeks ago

    Mumbai, Maharashtra, India Isprava Full time

    - Position : Assistant Manager - Procurement - Real Estate- Position : Sr. Executive - Procurement - Real Estate- (Interior Purchase Background preferred)We also have Walk-In-Interviews : for the above positions:Date : 10th/11th March 2025Contact Person : Mr. Pereira / Interview Time : 10am to 4pmVenue : 42A, Impression House, GD Ambekar Marg, Kohinoor...

  • Assistant Manager/ Sr. Executive Procurement

    1 week ago

    Mumbai, Maharashtra, India Isprava Full time

    Walk-In-Interviews :for the below positions: Date : 10th/11th March 2025 Contact Person : Mr. Pereira / Interview Time : 10am to 4pm Venue : 42A, Impression House, GD Ambekar Marg, Kohinoor Mill, Wadala, Mumbai, Maharashtra 400031 GPS Link : : Assistant Manager – Procurement - Real Estate Position : Sr. Executive – Procurement - Real Estate ( Interior...

  • Assistant Manager/ Sr. Executive Procurement

    2 weeks ago

    Mumbai, Maharashtra, India Isprava Full time

    Position : Assistant Manager – Procurement - Real EstatePosition : Sr. Executive – Procurement - Real Estate(Interior Purchase Background preferred)We also have Walk-In-Interviews : for the above positions:Date : 10th/11th March 2025Contact Person : Mr. Pereira / Interview Time : 10am to 4pmVenue : 42A, Impression House, GD Ambekar Marg, Kohinoor...

  • Assistant Manager/ Sr. Executive Procurement

    1 week ago

    Mumbai, Maharashtra, India Isprava Full time

    Position : Assistant Manager – Procurement - Real EstatePosition : Sr. Executive – Procurement - Real Estate(Interior Purchase Background preferred)We also have Walk-In-Interviews : for the above positions:Date : 10th/11th March 2025Contact Person : Mr. Pereira / Interview Time : 10am to 4pmVenue : 42A, Impression House, GD Ambekar Marg, Kohinoor...

  • Sr. Executive

    2 weeks ago

    Mumbai, Maharashtra, India Rentokil Initial Full time

    PURPOSE OF ROLE:About the Role:The Sr. Executive  –Supply Planning is responsible for efficiently managing inventory at the warehouse , co-ordination with procurement colleagues and ensuring the indents are delivered timely. Manager - Procurement. The incumbent will have to work as part of a multi-functional team and this involves collaboration with the...