Manager/Sr. Manager

3 days ago

Navi Mumbai, Maharashtra, India Umedica Labs Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Role & responsibilities

  • Regulatory Submissions:

  • Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDA

  • Manage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports)

  • Ensure compliance with current USFDA regulations and guidance documents

  • FDA Interactions:

  • Prepare and submit FDA meeting requests and meeting packages (Type B, C meetings)

  • Participate in and support FDA meetings as the regulatory lead

  • Handle Controlled Correspondence with the FDA for product development and regulatory strategy

  • Product Expertise:

  • Provide regulatory support for complex formulations, including injectables and liquid dosage forms

  • Collaborate with R&D, QA, QC, and manufacturing teams to ensure regulatory alignment throughout the product lifecycle

  • Leadership & Communication:

  • Lead a team of regulatory professionals, providing guidance, training, and performance management

  • Communicate effectively with internal stakeholders and external regulatory bodies

Preferred candidate profile

  • Masters degree in Pharmacy
  • 12–15 years of experience in US Regulatory Affairs with a proven track record in ANDA/NDA submissions
  • Hands-on experience with FDA meetings, Controlled Correspondence, and post-approval changes
  • Strong understanding of injectables, liquid dosage forms, and complex generics
  • Excellent written and verbal communication skills
  • Demonstrated leadership and team management capabilities

  • visa executive

    7 days ago

    Navi Mumbai, Maharashtra, India The Visa Manager Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company DescriptionThe Visa Manager simplifies business travel by making visa processing easy for businesses. We specialize in B2B visa services, ensuring hassle-free applications for employees, clients, or partners. As an authorized vendor for six countries, including China, Brazil, Turkey, the Philippines, Japan, and Thailand, we provide fast, reliable,...

  • Sr. Manager

    2 weeks ago

    Navi Mumbai, Maharashtra, India Hindustan Platinum Full time ₹ 1,20,000 - ₹ 3,00,000 per year

    Hiring for Sr. Manager / AGM Production.A mid-level role, which involves overseeing the production of Catalyst and Refining. Will oversee all day to day operations of the plant from production / manufacturing, to ensuring all policies and procedures are followed. Develop processes that will maximize stewardship, safety, quality and productivity.Daily...

  • Manager/Sr. Manager-Accounts

    3 days ago

    Navi Mumbai, Maharashtra, India Dinesh Engineers Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Role- Manager/Sr. Manager-Accounts & Finance Only Qualified CABook KeepingStatutory &Internal Auditfinancial MISBudgeting &ForecastingInternal Policy review/System development Location: Navi Mumbai Kindly share resume

  • Sr. Manager

    7 days ago

    Navi Mumbai, Maharashtra, India Titan Laboratories Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    We are looking for Sr. Manager/ AGM handling International Sales for GCC with Asia market and will be based at Juinagar, Navi Mumbai.Roles & Responsibilities:Creating new Market, New clients for the company.Make sure of good profitable and sustainable business for the companyFollow-up from client for order, collection, product development & market...

  • Sr. Manager Contracts

    7 days ago

    Navi Mumbai, Maharashtra, India Omkar Placements Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Our client leading Real Estate Company is looking for : Sr. Manager / DGM Contracts ProfileDriving the overall Contracts processFloating of enquiries/calling for quotations/tenders from contractorsTechno commercial assessment of bids received Required Candidate profileRate Analysis & NegotiationContract Development & DraftingContract Implementation &...

  • Sr. Executive/Asst. Manager

    2 weeks ago

    Navi Mumbai, Maharashtra, India Crown HR Services Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Job Opening for Sr. Executive/Assistant Manager- Technical Sales at reputed MNC at Navi Mumbai & Pune location having relevant experience of 2-8 years

  • Sr. Manager to AGM

    7 days ago

    Navi Mumbai, Maharashtra, India Sulzer Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    FE_Energy-E407Sr. Manager to AGM - Indirect Sourcing - Full Time - Navi Mumbai, IndiaSulzer is a leading engineering company with a proud heritage of innovation. Join our global team to grow your expertise and develop innovative solutions that enable a prosperous and more sustainable society.We are looking for a Sr. Manager to AGM - Indirect Sourcing to join...

  • Sr. Manager/Manager

    7 days ago

    Mumbai, Maharashtra, India Anagh Management Services Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Hiring Sr. Manager/Manager – FP&A & Costing (Plant, Ujjain). Handle budgeting, cost control, SAP product costing, MIS, and financial analysis. Must be CMA/MBA with 7–10 yrs in food/FMCG mfg. Strong SAP, Excel, and costing knowledge needed.

  • Manager/ Sr. Manager- Sales

    2 weeks ago

    Navi Mumbai, Maharashtra, India calyx pharma Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Job Title: Manager / Sr. Manager Sales & Marketing (APIs)Location: Vashi, Navi MumbaiDepartment: Sales & MarketingReporting To: Marketing HeadAbout UsCalyx Chemicals & Pharmaceuticals Ltd. is a leading manufacturer and supplier of Active Pharmaceutical Ingredients (APIs). With a strong global presence and focus on innovation, we are committed to delivering...

  • Sr. Manager

    7 days ago

    Mumbai, Maharashtra, India BSL Scaffolding Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role – Sr. Manager – FinanceLocation – MumbaiQualification: MBA/Masters + BcomExperience: 8+ years in core finance functions in a manufacturing Prioritization,Compliance,Reconciliation,Budgeting,Forecasting,CashFlow,Controls,