Ophthalmic Regulatory Filing Manager Required For ANDA Markt

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring...

Job Title:Regulatory Affairs Specialist Med/Pharma (Female)Location:RemotePosition Overview:We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring...

Greeting from Ipca Laboratories Opening in Regulatory Affairs FormulationQualification : B pharma /M Pharma /MscExperience : 12-14 years regulatory affairs experience majorly in USA market for Solid oral dosage formsDesignation : Assistant General ManagerLocation : KandivaliKey Responsibilities:Ensure timely submission of ANDAs, supplements and...

Job DescriptionAjanta Pharma is looking for Research Associate- Method Development- Ophthalmic to join our dynamic team and embark on a rewarding career journey Design and validate analytical methods for ophthalmic drugs Conduct laboratory testing and data interpretation Ensure regulatory compliance and documentation accuracy Collaborate with R&D and...

Job Description – Regulatory Affairs CMC Associate (US Market) We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities. Key Responsibilities: Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format....

Job Description Review of outsourced DMF and deal with suppliers for adequate data for ANDA/MAA/ ANDS filings.Responsible for arranging the documentation required for regulatory submissions to US/Europe/ all other geographies - new DMF submissions Amendments, Response to Deficiencies.To provide Regulatory inputs during product development, manufacturing, and...

Experience - 5- 11 YearsQualification- B. Pharm / M. PharmRESPONSIBILITIES- Author high- quality CMC documentation for US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidances assuring technical congruency and regulatory compliance.- Identify the required documentation for US...

Role & responsibilitiesAuthor high- quality CMC documentation for US FDA submissions (Original ANDA/Deficiency responses/Post approval supplements/Annual reports) in accordance with latest guidance assuring technical congruency and regulatory compliance.Identify the required documentation for US regulatory submissions and negotiate the delivery of approved...

Role & responsibilitiesRegulatory Submissions:Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDAManage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports)Ensure compliance with current USFDA regulations and guidance documentsFDA Interactions:Prepare and submit FDA meeting requests and meeting...

1.  Position: Head Formulation Development (R&D) with strong exposure to regulated markets (US, EU)for US Markets  2.  Experience: Minimum 22+ years in formulation development, with at least 8-10 years in a leadership role  3.  Education: M.Pharm / Ph.D. in Pharmaceutics  4.  Key Responsibilities:     *   Lead formulation development activities...