Assistant Manager

1 week ago

Mumbai, Maharashtra, India Umedica Laboratories Private Limited Full time ₹ 15,00,000 - ₹ 20,00,000 per year

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.

UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.

We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.

As part of our further expansion and growth plans, we are looking to hire
Assistant Manager / Manager Regulatory Affairs –
Complex Products
an aggressive / dynamic Regulatory Affairs Professional.

This position is based at our
R&D center at Turbhe Navi Mumbai and will report to the Head Regulatory Affairs.

The remuneration package will be commensurate with the incumbent's professional experience and will be in line with market standards.

Essential skills and experience:

The incumbent must have min. 10+ years' experience in the pharmaceutical industry with a minimum of 10-12 years' experience handling Regulatory compliance across the US, European and UK market specializing in
505(b)(2) NDAs, Hybrid Applications, IND submissions, and complex drug approvals.

. Specifically, the incumbent will be responsible for:

  • Preparation and Submission of Pre-IND meetings Request and Packages and IND/NDA submissions ensuring compliance with FDA & EMA.
  • Define nonclinical and clinical study requirements for 505(b)(2), including bridging studies.
  • CTD dossier preparation (Modules 1-5) and CMC document review.
  • Address comparability studies, bioequivalence challenges, and formulation complexities.
  • Manage post-approval variations, renewals, and compliance updates.
  • Engage in EMA scientific advice meetings and FDA Pre-IND consultations.

Required Skill:

  • Expertise in 505(b)(2), IND/NDA/Hybrid Applications, and CMC compliance for US/EU.
  • Strong knowledge of EMA/FDA guidelines, clinical trial regulations, and GMP standards.
  • Experience with eCTD submissions, CMC documentation, and regulatory risk mitigation.
  • Familiarity with eCTD software's for regulatory submissions.
  • Experience on the labeling updates required for complex product for 505b2.
  • Experience on Pediatric Study Plan Submission and Approval, Post approval Study Requirements
  • Experience on PDUFA Fees Requirements and Waiver Applications

Preferred Education requirements:

Bachelor's/master's in pharmacy, or Regulatory Affairs.

Candidate having Certifications in Regulatory Compliance or Drug Development Clinical Studies preferred.

  • assistant manager

    1 week ago

    Mumbai, Maharashtra, India Hyatt Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    SummaryYou will be responsible to assist with the efficient running of the department in line with Hyatt International's Corporate Strategies and brand standards, whilst meeting employee, guest and owner expectations. The Assistant Manager - Human Resources is responsible to assist in the smooth and efficient running of the Personnel Department in the Human...

  • Assistant Manager

    1 week ago

    Mumbai, Maharashtra, India Tax Diva Consulting LLP Full time ₹ 5,00,000 - ₹ 10,00,000 per year

    Role Description This is a full-time on-site role located in Vile Parle Eastfor an Article Assistant and Assistant Manager. The Assistant Manager will be responsible for managing tax advisory engagements, ensuring compliance, conducting due diligence, and supporting Virtual CFO services. They will also assist in startup consulting, financial projections,...

  • Assistant Manager

    1 week ago

    Mumbai, Maharashtra, India Tax Diva Consulting LLP Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Role DescriptionThis is a full-time on-site role located in Vile Parle Eastfor an Article Assistant and Assistant Manager. The Assistant Manager will be responsible for managing tax advisory engagements, ensuring compliance, conducting due diligence, and supporting Virtual CFO services. They will also assist in startup consulting, financial projections,...

  • Assistant Manager

    1 week ago

    Mumbai, Maharashtra, India Datamark, Inc. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    DATAMARK, Inc. is seeking an experienced Assistant Manager - Human Resource Operations to join our dynamic team. This role is pivotal in enhancing HR operations and ensuring effective implementation of policies and practices within the organization. The Assistant Manager will assist in managing various HR functions, including employee relations, compliance,...

  • Assistant Manager

    1 week ago

    Mumbai, Maharashtra, India St. Regis Hotels & Resorts Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Additional InformationJob Number Job CategoryHuman ResourcesLocationThe St. Regis Mumbai, 462, Senapati Bapat Marg, Mumbai, Maharashtra, India, 400013VIEW ON MAPScheduleFull TimeLocated Remotely?NPosition TypeManagementJob SummaryAssists in carrying out the daily activities of the Human Resource Office including recruitment, total compensation, and training...

  • Assistant Manager

    1 week ago

    Mumbai, Maharashtra, India Marriott International Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Additional InformationJob Number Job CategoryHuman ResourcesLocationThe St. Regis Mumbai, 462, Senapati Bapat Marg, Mumbai, Maharashtra, India, 400013ScheduleFull TimeLocated Remotely?NPosition Type ManagementJOB SUMMARYAssists in carrying out the daily activities of the Human Resource Office including recruitment, total compensation, and training and...

  • Assistant Manager

    1 week ago

    Mumbai, Maharashtra, India Dhruv Corporate (HR) Solutions Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 7,00,000 per year

    This role is for one of the valuable clients of DCSPL which is a CA Firm. Role Summary: We are seeking a candidate with over 6 years of experience in Indirect Tax (preferably from a CA or consultancy firm) to manage and support engagements related to GST, VAT, Service Tax, and other indirect tax matters. The ideal candidate will be responsible for assisting...

  • Assistant Manager

    1 week ago

    Mumbai, Maharashtra, India ENTERPRENEUER PR Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Company DescriptionWe suggest you enter details here.Role DescriptionThis is a full-time on-site role for an Assistant Manager at ENTREPRENEUR PR, located in Mumbai. The Assistant Manager will be responsible for managing day-to-day operations, developing and implementing strategies, coordinating with different departments, and ensuring smooth workflow. Other...

  • Assistant Manager

    2 days ago

    Mumbai, Maharashtra, India Fusion CX Full time

    Job DescriptionJob descriptionFusion CX is looking for Assistant Manager - Healthcare to join our dynamic team and embark on a rewarding career journey- Assist in managing healthcare facility operations and staff.- Ensure compliance with healthcare regulations and standards.- Monitor and improve patient care quality and safety.- Oversee administrative...

  • Assistant Manager

    1 week ago

    Mumbai, Maharashtra, India Welspun New Energy Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    As the Assistant Manager - Strategy, you will play a critical role in supporting the strategic planning and execution of business initiatives within the renewable energy sector. You will assist in developing long-term business strategies, conducting market analysis, and identifying growth opportunities to position the company as a leader in the renewable...