CMC Manager

4 weeks ago

india Vita Green Health Product Company Limited Full time

Job Purpose:

The position will be overseeing Chemistry, Manufacturing, and Controls (CMC) activities, ensuring the highest quality and compliance standards. Responsibilities will encompass a range of tasks, including technical writing, collaboration with manufacturing sites, and close coordination with Quality Assurance (QA) and Quality Control (QC) functions.

Main Tasks:

CMC Oversight:

  • Manage all aspects of CMC activities for pharmaceutical and consumer health products, encompassing formulation development, process optimization, and analytical methods.

 

Technical Writing:

  • Develop and maintain precise technical documentation, including CMC regulatory submissions (INDs, NDAs, MAA, Food supplement dossier, Cosmetics etc.).
  • Create and update product specifications, master batch records, and standard operating procedures.

 

Manufacturing Site Liaison:

  • Serve as the primary point of contact between the organization and manufacturing sites.
  • Collaborate closely with manufacturing teams to ensure alignment with CMC strategies and objectives.

 

Quality Assurance/Quality Control Collaboration:

  • Work collaboratively with QA and QC teams to implement and maintain quality standards throughout the manufacturing process.
  • Participate in the development and execution of quality initiatives.

 

Regulatory Compliance:

  • Stay abreast of regulatory changes and industry trends impacting CMC requirements.
  • Ensure ongoing compliance with relevant regulations and guidelines.
  • Prepare and review CMC sections of regulatory submissions to health authorities.

 

Process Optimization:

  • Identify opportunities for process improvements and efficiency enhancements in collaboration with manufacturing teams.
  • Implement changes to enhance the robustness and reliability of manufacturing processes.

 

Supply Chain Coordination:

  • Collaborate with supply chain teams to manage inventory levels and ensure timely production and distribution.
  • Implement strategies to enhance the reliability of the supply chain for pharmaceutical and consumer health products.

Requirements

  • Bachelor's or advanced degree in a relevant scientific or engineering discipline.
  • Proven experience in CMC management within the consumer health or related industries.
  • Technical writing expertise with the ability to articulate complex CMC concepts in regulatory submissions.
  • In-depth knowledge of formulation development, process optimization, and analytical methods in a consumer health context.
  • Familiarity with regulatory requirements and guidelines related to consumer health products.
  • Project management skills to oversee CMC processes and timelines.
  • Effective communication skills to liaise with manufacturing, QA, QC, and regulatory teams.
  • Collaborative mindset with the ability to work across functional areas.
  • Knowledge of quality systems and practices in the pharmaceutical or consumer health sector.
  • Adaptability to evolving industry standards and regulatory landscapes.

Benefits

We offer you...

  • Growth Opportunities for strong performers
  • Flexible working schedule
  • Chance to work on cutting edge technology
  • Fun working culture

#LI-CJ

  • Regulatory Affairs Specialist

    2 months ago

    india Apsida Life Science Full time

    Regulatory Affairs Specialist - CMC Variations/Submissions 12 month contract - Immediate start Overview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes. Key Responsibilities: CMC Change Control...

  • Regulatory Affairs Specialist

    2 months ago

    India Apsida Life Science Full time

    Regulatory Affairs Specialist - CMC Variations/Submissions12 month contract - Immediate startOverview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes.Key Responsibilities:CMC Change Control Assessment:...

  • 072 CMC Specialist

    1 month ago

    india ProductLife Group Full time

    MAIN RESPONSIBILITIES Provide technical support (internally and during meetings with prospects) and content for the preparation of proposals Represent the company in forums and conferences where he/she acts as an expert on a subject Prepare or review CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files). ...

  • CMC Regulatory Associate

    3 days ago

    india Par Formulations Full time

    Description Collate and review CMC documents (i.e. Master Formula Card, PDR, BMR, BPR, Specifications, Validation reports etc.) from F&D, ADL, QA, production, packaging department and review of data for ANDA preparation, deficiency response, annual reports and supplements. Prepare and review the ANDA’s sections. Compile controlled...

  • Scientist - CMC (Analytical)

    1 month ago

    india Ferring Pharmaceuticals Full time

    Job Description: Role : Scientist  Reports to : Associate Director - CMC (Analytical) Location : Hyderabad, India Purpose of the Role : Work both as individual contributor and in collaboration with team to facilitate & drive timely achievement of CMC & R&D objectives, from CMC (Analytical) function. Qualification : Ph.D (preferred), M. Pharma/M.Sc in...

  • Director, CMC, FDA Experience

    2 months ago

    india Allucent Full time

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a Director, CMC at...

  • Director, CMC, FDA Experience

    1 month ago

    india Allucent Full time

    DescriptionAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a...

  • Director, CMC, FDA Experience

    1 month ago

    India Allucent Full time

    DescriptionAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a...

  • Regulatory Affairs Specialist – CMC 215

    2 months ago

    india ProductLife Group Full time

    Specific activities and responsibilities: Review the drug product dossier section ( specifically 3.2.P.2 and 3.2.P.3 ) as per the EU regulatory requirement. Aware of regulatory requirements, and technical knowledge of various pharmaceutical dosage forms. Project coordination and management skills CMC regulatory requirements for other than...

  • Regulatory Affairs

    2 weeks ago

    india Integrated Services For Productivity & Validation, Inc Full time

    Job Description Preferred qualifications are: • Experience in manufacture, quality or distribution in Pharmaceutical/Biotech industry • Strong oral and written communication skills in English and Spanish • Proficiency working with teams at different levels• Able to operate in a fast paced, dynamic environmentResponsibilities • Support site...

  • Regulatory Affairs

    3 days ago

    india Integrated Services For Productivity & Validation, Inc Full time

    Job Description Preferred qualifications are: • Experience in manufacture, quality or distribution in Pharmaceutical/Biotech industry • Strong oral and written communication skills in English and Spanish • Proficiency working with teams at different levels• Able to operate in a fast paced, dynamic environmentResponsibilities • Support site...

  • Regulatory Affairs Manager

    1 month ago

    india USV PRIVATE LIMITED Full time

    Organisation : USV, a top -15 pharmaceutical company in India, excels in the diabetes and cardio sectors. With a presence in over 65 countries, our dynamic team of over 7,000 spans generations. Our commitment to brand building is evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase and more. Responsibilities: For the CMC RA...

  • Value Added Services

    2 months ago

    India DSRP Enterprises Full time

    **Responsibilities**: 1. To promote and sell maintenance services a) To convert AMC (Annual Maintenance Contracts) to CMC (Comprehensive Annual Maintenance Contracts), b) Convert non-AMC, CR (Chargeable Repairs), Out of warranty instruments in AMC / CMC c) To promote PM kits (Preventive Maintenance Kits) to CR and AMC customers 2. To promote and sell...

  • Sr. Associate Regulatory Affairs

    5 days ago

    india QRC Group, LLC Full time

    Job Description Sr. Associate Regulatory Affairs with experience in manufacture, quality, or distribution in Pharmaceutical or Biotech Industry.Responsibilities: Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations, variations/supplements, country specific documents coordination).Provide and maintain CTA/MA...

  • Associate - Regulatory Affairs

    3 weeks ago

    india Par Formulations Full time

    Description Collate and review CMC documents (i.e. Master Formula Card, PDR, BMR, BPR, Specifications, Validation reports etc.) from F&D, ADL, QA, production, packaging department and review of data for ANDA preparation, deficiency response, annual reports and supplements. Prepare and review the ANDA’s sections. Compile controlled...

  • Sr. Associate Regulatory Affairs

    2 weeks ago

    india QRC Group, LLC Full time

    Job Description Sr. Associate Regulatory Affairs with experience in manufacture, quality, or distribution in Pharmaceutical or Biotech Industry.Responsibilities: Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations, variations/supplements, country specific documents coordination).Provide and maintain CTA/MA...

  • Associate - Regulatory Affairs

    3 weeks ago

    india Endo Full time

    Job Description Summary Regulatory Affairs Associate is responsible for the timely preparation and submission of adequate and accurate ANDAs and supplements in eCTD format through effective interactions with various stakeholders pertaining to documents that are a part of submission. Also can responsible for oral solids (tablets, capsules) or sterile...

  • Managed Medicaid Collector

    1 week ago

    India HealthRecon Connect Full time

    Full Time - India - Posted 3 months ago HealthRecon Connect provides technology-enabled Revenue Cycle Management solutions to US healthcare providers. The company leverages over 30 years of deep domain expertise, machine learning, AI, cutting-edge analytics, and automated workflows that help improve cash flow, patient outcomes and enable peace of mind for...

  • Senior Manager Contract Manufacturing

    2 months ago

    india Ferring Pharmaceuticals Full time

    Job Description: Experience: Minimum 10 years of experience in drug product manufacturing / Production of oral dosage form and sterile products Experience of FDA Approval in the Production/ Manufacturing area (Various Pharmaceuticals Dosage forms)  Should be Competent Technical person & Registered Pharmacist Should have Production experience, thorough...

  • Senior Manager Contract Manufacturing

    2 weeks ago

    india Ferring Pharmaceuticals Full time

    Job Description: Experience: Minimum 10 years of experience in drug product manufacturing / Production of oral dosage form and sterile products Experience of FDA Approval in the Production/ Manufacturing area (Various Pharmaceuticals Dosage forms)  Should be Competent Technical person & Registered Pharmacist Should have Production experience, thorough...