56 Jobs in Dholka

Role : Senior Manager Regulatory Affairs

Job Description:

Handling submissions in Sugam & NSWS Portal

Preparation & Submission of o New Drug applications, Subsequent New Drug Applications

Clinical trial application - Phase I, II, III, IV (Form CT-04)

BA/BE Export application (Form CT-05)

Test License application (Form CT-10, Form CT-13, Form CT-14, Form CT-16, Form-11)

Manufacturing new drug & Marketing (MA) application (Form CT-21)

Import new drug & Marketing application (Form CT-18)

Form-40 & Form-10 application

Post approval changes

RCGM Submission o for R&D activities o Pre-clinical toxicity study of vaccines (Form C-1, Form C-3b)

Dual use NOC application

Import and export application of Narcotic & Psychotropic substance

Submission of Quarterly returns to CBN, Gwalior

(Note: Local Candidate required from Ahmedabad )

Company : Cadila Pharmaceutical Ltd.

About Us : Cadila Pharmaceuticals Ltd, is one of the Largest Privately- held Pharmaceuticals companies in India. Over the past seven decades, We have been developing and manufacturing affordable medicines for the patients around the world.

About the Role

A Regulatory Affairs Executive for the Africa market plays a critical role in ensuring products comply with regional regulations and maintaining market access across diverse countries. This position requires a blend of technical expertise, communication, project management, and analytical skills to navigate the complex regulatory landscape in Africa

Responsibilities

• Preparation and submission of registration and re-registration dossiers as per country requirements i.e. African countries, FWA countries and Nepal
• Submission of various original documents for notarization, chamberization and legalization which forms an important part of dossier.
• Arrangement for Indent of Samples, Packing Material specimen, Impurities, Reference Standards as per MOH requirement.
• Establish Coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame.
• Post approval activities: Submission of variations to the terms of marketing authorizations for finished products as per respective variation guideline.
• Preparation of COPP's (Certificate of Pharmaceutical Product) and FSC to be submitted to Local FDA approvals.
• Preparation of Tender documents.
• Enhance self-awareness about changing regulatory requirements.

Qualifications

M. Pharma/B.Pharma

Required Skills

Having experience in Pharmaceutical Industries in African Market

• Verify Receipt of Raw Material & Packaging Material for stores. • Verify SAP data entries like GRN, Issuance, Transfer posting, reservations, SAP report generation etc. • Verify the environmental parameters like Temperature, RH, pressure difference etc. • Verify Daily verification of weighing balance and daily documentation. • Verify Reconciliation of materials. Stock verification with internal and external auditors. • Verify to Maintain of Rack location in SAP as per physical. • Verify Preparation of packing list and keep ready the material for Ethiopia. • Verify timely dispatch of material to Loan license and Ethiopia plant. • Verify handling of retest, rejected, expired materials. • Co-ordinate with quality control / production / maintenance /QA / SCM/ Purchase / Contract Mfg etc. departments. For smooth functioning of stores activities. • Compliance to cGMP with respect to regulatory standards. • Maintaining & verify the proper housekeeping in Stores area. • Training attends as per schedule. • Revise or change the Store SOP for comply to any Audit/ for as per time schedule. • Ensure receipt and on-line documentation of the materials received as per SOP. • Ensure all the operating systems are maintained as per the SOP. • To receive the materials as per the amended approved vendor list. • Ensure no loss of production due to non-availability of dispensed materials. • Ensure clearance of obsolete, rejected and Artwork change materials on timely basis with coordination with Planner. • Ensure to carry out GMP self-inspection within the department once in a month and compliance on the observed deviations. • Ensure no major observation during internal as well as external audits • Ensure 100% compliance to the existing and no unplanned deviation on the shop floor • To review and correct gaps between SOP and policies and implement the audit (internal & external) findings.

HPLC Analyst Job Description (QC Department)

Responsible for operating ampoule filling and capping machine at Dholka premises. • Should have knowledge of Operating and maintenance of ampoule filling • To do aseptic and processing area entry exit procedure properly with proper gowning. • Should have knowledge of working in aseptic and processing area. • Repair and maintenance of all machines of parenteral manufacturing area. • To check and ensure that differential pressure and Temperature of the aseptic area and processing area are within limit and record it properly. • To check and ensure that pressure differential of all Laminar Air Flow are within limit and record it properly. • To check on line in process parameters like temperature, RH, DP, fill volume, quality of sealing at specific interval as mentioned in respective MMDI and SOPs. • To ensure proper inter personal relationships (IPR) in the section. • To ensure proper cleaning of the working areas. • To ensure proper status labeling as per Sop. • To ensure the all required documents to comply cGMP. • Reporting to Shift In charge for routine activities & special assignment given by seniors. Submit reports on performance and progress • To ensure calibration certificates of all measuring instruments comply with norms. • To review daily production and to discuss other issues."

Job Title : Senior General Manager - RA (DCGI)

Location : Dholka, Near Ahmedabad, Gujarat

Job Profile:

•Liaison with regulatory authorities/government bodies, coordination with customers/consultants - DGCI and India Regulatory bodies

•Provide regulatory advice to cross-functional departments right from the development stage leading to a scientifically sound regulatory submission within committed project timelines

•Provide regulatory inputs and frame up strategy of regulatory submission during business development discussions with international customers and the International Marketing Division

•Guidance to the regulatory/quality team to perform their respective functions efficiently and accurately. Identify team member's capabilities to perform and assign additional responsibilities accordingly. Adopt the role of a mentor to team members both personally and professionally.

•Facilitate in preparing compliance to GMP audit observations for own facilities

•Guide cross-functional departments on the implementation of systems for regulatory expectations and compliance

•Review of technical and investigation reports, summaries for adherence to regulatory guidelines and to provide guidance to cross functional technical teams for the requirement and content of regulatory documentation

•Evaluation of Day to Day operational issues w.r.t regulatory implications and providing short term and long term mitigation measures

Job Title: Research Associate – Analytical Development Laboratory (ADL)

Department: Research & Development (API Manufacturing)

Location: Dholka, Ahmedabad, Gujarat

Position Summary:

We are seeking a highly skilled and detail-oriented Research Associate – ADL to join our API R&D team. The selected candidate will be responsible for the development, validation, and transfer of analytical methods for Active Pharmaceutical Ingredients (APIs). The role plays a critical part in ensuring product quality, supporting process development, and facilitating regulatory compliance across the API lifecycle.

Key Responsibilities:

• Develop and validate analytical methods for raw materials, intermediates, and APIs using techniques such as HPLC, GC, UV, IR, KF, and titration.
• Support API process development teams by analyzing in-process samples, final products, and impurities.
• Characterize degradation products and impurities using advanced analytical tools (e.g., LC-MS, GC-MS, NMR – if available).
• Perform routine and non-routine analysis to support R&D, stability studies, and method transfer activities.
• Conduct analytical method transfers to QC and manufacturing sites (internal or external).
• Prepare and review analytical documentation, including method validation protocols, reports, SOPs, and COAs.
• Ensure adherence to GLP, cGMP, and data integrity standards during all analytical activities.
• Maintain laboratory instruments and troubleshoot minor issues to minimize downtime.
• Participate in OOS investigations, deviations, and CAPA implementations.
• Collaborate closely with cross-functional teams including process chemistry, regulatory affairs, and quality assurance.

Qualifications:

• M.Sc. in Analytical Chemistry / Organic Chemistry / Pharmaceutical Chemistry or related discipline.
• 2 to 5 years of experience in ADL for API R&D.

Ensure efficient operation and maintenance of Utility (Boiler, chilling plant, Air compressor, cooling tower and N2 System). • To ensure strict compliance of cGMP requirements & Good Engineering Practice requirements besides other statutory laws, rules and regulations. • To implement Cost reduction measures in the operation of the Utility. • To prepare and maintain SOP and documents related to machine operation and maintenance. • To identify probable cause/potential non-conformity to any breakdown/abnormal condition. • To perform breakdown maintenance activity as and when applicable. • Review machine operation related documents and equipment log books. • To prepare schedule for planned activities like preventive maintenance, filter replacement, pump changeover, and to ensure execution as per defined schedule. • To help QA team in equipment validation/qualification, and review of concerned documents. • To ensure effective engineering support to help all the production facilities located at Dholka.To maintain safety practice during plant operation and maintenance.

Role : Senior Manager Regulatory Affairs

Job Description:

Handling submissions in Sugam & NSWS Portal

Preparation & Submission of o New Drug applications, Subsequent New Drug Applications

Clinical trial application - Phase I, II, III, IV (Form CT-04)

BA/BE Export application (Form CT-05)

Test License application (Form CT-10, Form CT-13, Form CT-14, Form CT-16, Form-11)

Manufacturing new drug & Marketing (MA) application (Form CT-21)

Import new drug & Marketing application (Form CT-18)

Form-40 & Form-10 application

Post approval changes

RCGM Submission o for R&D activities o Pre-clinical toxicity study of vaccines (Form C-1, Form C-3b)

Dual use NOC application

Import and export application of Narcotic & Psychotropic substance

Submission of Quarterly returns to CBN, Gwalior

(Note: Local Candidate required from Ahmedabad )