Ahmedabad, Gujarat, India · On-site
Job Responsibility: Regulatory Affairs Must have expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic sterilization or Terminal sterilization or both technique…
Skills: Regulatory Affairs, CMC Strategy, ANDA Submissions, NDA Submissions, IND Submissions
India · On-site
JD: To prepare and modify all drawings managed by engineering department as per the requirements. Co-ordinate with inter department for timely closure of Change Control, Corrective Action and Preventive Action (CAPA), De…
Skills: Auto Cad, JD Edwards, Quality Management System, SOP Preparation, Inventory Management
Baton Rouge, Louisiana, United States · Remote OK
$80k–$100k/yr
Description: The Sales Representative plays a crucial role in implementing marketing & sales strategies to promote our products effectively with our ENDO Sales Team. The incumbent will deliver balanced and informative sa…
Skills: Communication, Presentation Skills, Disease State Knowledge, Pharmaceutical Sales, Medical Device Sales
Bridgewater, New Jersey, United States · Remote OK
$110k–$140k/yr
Description: The Sales Representative implements tactics as defined by the Marketing and Sales plans for the Neurology Team. They deliver balanced sales presentations to a defined list of current and prospective customer…
Skills: Communication, Presentation Skills, Disease State Knowledge, Pharmaceutical Sales, Medical Device Sales
Bridgewater, New Jersey, United States · On-site
$130k–$145k/yr
Description: The Digital Marketing Manager is responsible for driving digital marketing performance and serving as the business owner of Amneal's digital commerce platform Amneal Direct. This role leads digital engagemen…
Skills: Digital Marketing Strategy, eCommerce Platform Management, SEO/SEM, Digital Analytics, Vendor Management
Ahmedabad, Gujarat, India · On-site
Description: Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches. Maintaining the area and equipment in order…
Skills: Manufacturing Process Operations, cGMP, USFDA Compliance, Granulation, Batch Manufacturing Records
Ahmedabad, Gujarat, India · On-site
Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches. Maintaining the area and equipment in orderly manner as …
Skills: Manufacturing Process Operations, cGMP, Online Documentation, SOP Training, IQ/OQ/PQ
Ahmedabad, Gujarat, India · On-site
Part of Technology Transfer Team (Under R&D vertical ) at Pipan location Responsible for Preparation of Master BMR, BPRs and document management. Responsible for coordination with various departments like Regulatory Affa…
Skills: Technology Transfer, Master BMR Preparation, BPR Management, Scale-up Execution, Exhibit Batches
Ahmedabad, Gujarat, India · On-site
Primary Responsibilities (Key Accountabilities) 1) Dossier Compilation & Submission (US/EU/Canada) Lead compilation, review, and finalization of dossiers for regulated markets, primarily for US (ANDA/505(b)(2) and, EU fo…
Skills: Dossier Compilation, Regulatory Strategy, 505(b)(2) Applications, CMC Changes, FDA Guidance
India · On-site
1 cGMP and compliance review in the GMP area as per cGMP guideline. 2 Machine and area clearance. 3 Sampling of blend, intermediate stages, AQL finished product, ANSI sample, reserve sample, stability sample and In-proce…
Skills: cGMP Compliance, In-Process Quality Assurance, Sampling, BMR/BPR Review, Equipment Calibration
Ahmedabad, Gujarat, India · On-site
Required Skills: Strong knowledge of country specific regulatory labeling requirements Understanding of packaging materials and artwork processes Familiarity with labeling software/tools Attention to detail Strong coordi…
Skills: Regulatory Labeling, Artwork Management, Compliance Review, Team Leadership, Cross-functional Collaboration
Ahmedabad, Gujarat, India · On-site
Qualification: M.Sc. Chemistry or M.Pharm Experience: 8 -15 yrs Scientific review of external API vendor’s DMFs in context of ANDA/NDA & resolving any gaps.Preparation & review of ANDA/NDA Drug Substance Modules & relate…
Skills: Scientific Review, DMF Review, ANDA Preparation, NDA Preparation, Drug Substance Modules
India · On-site
Description: Responsible for managing regulatory affairs activities and regulatory strategy execution to ensure compliance with global regulatory requirements, industry standards, and ethical practices throughout product…
Skills: Regulatory Affairs, Regulatory Strategy, Dossier Compilation, DMF Compilation, eCTD Submissions
Ahmedabad, Gujarat, India · On-site
Description: This role is responsible for creating, reviewing, and maintaining technical documentation related to quality control processes and activities in compliance with established standards and regulatory requireme…
Skills: Technical Writing, Quality Control, GMP Compliance, GDP Compliance, SOP Development
Ahmedabad, Gujarat, India · On-site
Job Description: Prepare Stability Summary Reports (SSR) and related stability documentation.Track stability study status, report timelines, and documentation activities.Maintain stability records, reports, and supportin…
Skills: Stability Documentation, SSR Preparation, Document Tracking, Record Management, GMP
Ahmedabad, Gujarat, India · On-site
Description: Independently conduct and prepare investigation reports for Product Quality Complaints, Unplanned Deviations, OOS, OOT, and OOAL events, ensuring timely closure and regulatory compliance. Perform root cause …
Skills: Quality Management Systems, Root Cause Analysis, CAPA, Change Control, cGMP Compliance
Ahmedabad, Gujarat, India · On-site
Description: Prepare and review qualification protocols and reports for equipment, utilities, and systems (DQ, IQ, OQ, PQ, as applicable). Coordinate and monitor qualification activities with Engineering, Production, and…
Skills: QA Validation, Qualification Protocols, GMP Compliance, Risk Assessment, FMEA
Piscataway, New Jersey, United States · On-site
Description: The Scientist II - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written proce…
Skills: Chemical Analysis, IR Spectroscopy, UV-Vis Spectroscopy, Chromatography, X-ray Diffraction
Piscataway, New Jersey, United States · On-site
$18/hr–$22/hr
Description: Packaging Operator I is an entry-level role within the packaging department, responsible for the safe and efficient operation of packaging equipment. This position ensures in-process products are packaged in…
Skills: Packaging Equipment Operation, cGMP Compliance, SOP Adherence, Quality Control Checks, Documentation
Ahmedabad, Gujarat, India · On-site
Description: Prepare, review, and maintain Stability Summary Reports (SSRs) in accordance with approved stability protocols and regulatory requirements.Compile and evaluate stability data received from QC and Stability t…
Skills: Stability Summary Reports, Document Control, cGMP, Good Documentation Practices, Data Integrity
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Responsible for preparing and submitting high-quality IND, NDA, and ANDA dossiers to the US FDA, specifically for sterile dosage forms. The role involves developing CMC regulatory strategies, managing lifecycle changes, and coordinating with R&D and other departments to ensure timely approvals.
Requires a Bachelor's degree in Pharmacy (B. Pharm) with a Master's (M. Pharm) preferred and 5 to 8 years of experience in regulatory affairs. Must have specific expertise in sterile injectables, ophthalmic, or IV bag dosage forms and a strong working knowledge of FDA and ICH regulations.
Job Responsibility: Regulatory Affairs
Must have expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic sterilization or Terminal sterilization or both techniques.
Compile, prepare, review and submit IND, NDA and ANDA submissions along with associated Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible.
Develop and implement CMC regulatory strategies for IND/NDA and ANDA submissions, lifecycle management, and deficiency responses to ensure timely approvals.
Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
Ensure high quality, compliance-driven submissions aligned with cGMP, ICH, and FDA expectations. Drive first-cycle approval success, minimize deficiency rates, and ensure “Right First Time” submissions.
Prepare and finalize controlled correspondence as well as Pre-submission meeting package (Pre-ANDA, Pre-IND, Pre-NDA and EU scientific advisory meetings) to FDA on specific issues as needed for assigned projects.
Ensure timely submission of all assigned projects. Work very closely with all relevant departments at the time of product initiations, R&D phase, NDA/ANDA Execution and after initiation of stability to ensure availability of all documents to ensure timely submissions.
Assess the deficiency letter immediately after receipt from FDA, perform in-detail gap assessment and discuss with superiors to finalize the strategy to respond the deficiency.
Evaluate post-approval change controls and formulates strategies for correct filing categories, with minimal involvement of supervisor. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS.
Proactively raises major project issues to superior for resolution and agreement.
Be flexible in timings and available for teleconferences as per US team schedule.
Evaluate final compositions for IIG and Proportionality similar criteria’s and develop regulatory strategies to avoid acceptable for filing issues.
Review the API DMFs thoroughly and share the review comments to purchase department on-time. Follow up with purchase team or with DMF holder directly as needed to ensure compliance to provided comments on-time.
Responsibilities / Skills:
Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects.
Excellent written (Technical writing) and verbal communication skills and interpersonal skills.
Prior experience working with ANDAs, INDs, NDAs and FDA correspondences.
Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required.
Ability to communicate effectively and collaboratively as part of a team in a respectful manner.
Ability to interface with professionals domestically and abroad.
Ability to work independently, self-starter.
Working knowledge of ICH, FDA and 21 CFR regulations.
Should archive and maintain all submissions in a systematic way.
Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department.
Maintain current knowledge of regulations and other issues that affect products and industry.
Good problem solving skills and analytical ability.
Aware of eCTD regulations and health authorities expectation.
Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Power-point, Outlook and Adobe Professional is a must.
We make healthy possible.
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Offices: 400 Crossing Boulevard, Bridgewater, New Jersey 08807, US
We make healthy possible.
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Offices: 400 Crossing Boulevard, Bridgewater, New Jersey 08807, US
