Regulatory Affairs Manager Teva Pharmaceuticals

8.0 - 10.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

The Opportunity: The Manager is responsible for the supervision, critical review, and approval of established US Gx labeling documents filed under an ANDA/505(b)(2) by US and Mumbai/Bangalore (India locations) members while adhering to federal regulations, internal processes, and meeting timelines driven by company goals. The Manager will also be responsible for their own assignments, when needed, and working closely with other Managers surrounding the review and approval of labeling documents established for these projects. Additionally, the Manager will oversee all team databases and trackers and will update them when changes are required. The candidate must possess a firm knowledge of FDA US labeling regulations and guidances for products filed under an ANDA/505(b)(2). They should be a Subject Matter Expert (SME) in all facets of US labeling, including, but not limited to, SPL, PADERs, and AR compilation, in order to provide direction to direct reports. Finally, the candidate will be responsible for ensuring all required FDA reporting obligations are met in accordance with business objectives and regulations, maintaining compliance. Roles & Responsibilities: Hands-on leader in regard to daily workload; in addition to managerial responsibilities, this position could have independent work assignments to manage, when needed, as well as participate in the preparation of labeling submission documents. SME in the development, review, and electronic compilation of labeling documents to align with the RLD, FDA-solicited safety changes, company goals, and submission requirements for assigned ANDAs/505(b)(2)s per internal processes and prior to final disposition. Responsible for ensuring projects are assigned to direct reports and/or external team members in the US and Mumbai. Communicate, plan, prioritize, and perform training to ensure labeling documents meet all legal and regulatory requirements. Maintain the labeling tracker, ensuring all assigned projects remain on track by direct reports. SME in the development/review of Structured Product Labeling (SPL) documents (content and data elements) ensuring alignment with applicable FDA regulations and guidances. Work closely with Regulatory Operations to ensure assigned projects are submitted on time following the eCTD requirements related to labeling. Work closely with external departments to align with product/device strategy impacting the approved portfolio. Attend meetings relevant to the area of responsibility. Train and develop respective team members in the US and Mumbai. Create, revise, and/or train on SOPs/WIs, as appropriate. Maintain a metric of all team projects for reporting purposes. Maintain knowledge of US regulations, guidelines, and SOPs/WIs applicable to US Gx labeling. Experience in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities is preferred. Perform all other job-related duties as required by management. Experience & Qualification: M.Pharm/B.Pharm with a scientific or regulatory background, or an equivalent combination of education and experience. Total years of experience required for the role: Minimum 8+ years of US labeling experience and at least 1 year of supervisory experience preferred. Relevant years of experience: Minimum 6 to 7 years of pharmaceutical industry experience required, specifically in Regulatory Affairs and US ANDA/505(b)(2) labeling. Overall pharma industry experience: 6 to 7 years of US labeling experience. Show more Show less

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Senior Supervisor Plating Aarna Hr Solutions

8.0 - 10.0 years

3 - 7 Lacs

Gandhinagar, Maharashtra, India

On-site

Monitor the production quantity and quality during the product realization. Ensure optimal utilization of resources in plating and strive to exceed the department objectives Ensure QMS & EHS Policies are understood throughout the department Develop and maintain SOPs, WIs, Formats required for the department, along with the team Participate in goal setting process for the department & strive for excellence Develop FMEA, Control Plan and APQP documents related to Plating, along with the CFT Maintain house keeping standards & ensure safety measures PDCA for out of target conditions from DMB, initiate 8D for critical problems / QN's Identification of training needs of Plating department, work with HR / TQM / QA for implementing necessary trainings Participate in GLSS programs and strive for continual improvements Identify Continual Improvement projects within the department and ensure implementation of the same. To carry out SAP transaction in production module & monitor the same when delegated to SAP operator Skill Sets & Competencies Plating process knowledge, including chemistry preparation, chemistry trouble shooting, & chemical analysis such as AAS, pH, turbidity, conductivity, ORP, wet analysis, gravimetric analysis etc. Good exposure to Plating experiment using Hull cell technique Good exposure to waste treatment like coagulation, precipitation, co - precipitation & sedimentation Knowledge on water recycling using cross flow filtration in solid liquid filtration, RO technique Good knowledge in chemical handling and safety procedures Good knowledge of Statistics, 7 QC tools, FMEA, Control plan, basic lean manufacturing / six sigma awareness Good understanding of QMS, system requirements of Assembly area Should be able to understand & conduct PFMEA, Flow chart, Work instructions. Understand & implement on TQM requirements, good understanding of 8D & problem analysis. Understand & execute TS - 16949 requirement & comply to the same. Good communication skills Good understanding of SAP reports like Vital - sign, profitability, Inventory & Quality. If interested please send your UPDATED Profile with below mentioned details.

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