Executive - API Technical

APOTEX; Mumbai; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Apotex is seeking a senior professional to manage DMF reviews, regulatory submissions, and supplier interactions for APIs and excipients in the sourcing region. You will coordinate DMF activities, ensure compliance with regulatory filing requirements, and support NPD/PLCM initiatives across global teams.

You will work closely with regulatory affairs, formulation development, and quality groups to ensure timely approvals and uninterrupted material supply, with travel as required to supplier sites

Qualifications

• Knowledge of technical, quality compliance, and regulatory requirements related to sourcing APIs.
• Ability to read and interpret complex technical documents and write detailed business correspondence.
• Experience communicating with managers/directors and handling ambiguous concepts.
• Travel to supplier sites or industry events when required.

Responsibilities

• Lead reviewer for sourcing region originated DMFs to ensure rapid approvals.
• Ensure supplier DMFs conform to current filing requirements (ICH guidelines).
• Extract and disseminate information to support formulation development and specifications.
• Manage responses to DMF deficiencies to avoid delays in submissions and supply chains.
• Coordinate NPD/PLCM projects and site changes between suppliers and internal teams.
• Coordinate data flow for quality investigations (OOS, OOT, CAPA) with suppliers and QA.
• Collaborate with global API teams for DMF updates and portfolio management.
• Assist in API supplier selection and contribute content to GAPI databases.

Skills

API sourcing knowledge

Regulatory compliance

Quality assurance

Excellent communication

MS Office proficiency

Documentation

Travel willingness

Education

Science/Commerce background

Tools

MS Office

Job description

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Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

In this role, the incumbent will liaise and work directly with the appropriate functional groups within the Apotex group of companies and external raw material manufacturers on technical, quality, and regulatory matters for New Product Development (NPD), Product Life-Cycle Management (PLCM), and Commercial Projects related to active pharmaceutical ingredients (APIs) and excipients. Responsible to provide a high level of expertise with regards to drug master file (DMF) review, DMF deficiencies, DMF changes, also known as supplier driven changes, raw material out-of-specification (OOS)/out-of-trend (OOT) events resolution between Apotex and its suppliers.

This involves:

• Driving the technical aspects of raw material sourcing projects in the region or problem-event resolution by defining, planning, monitoring and reporting project progress/performance against timelines and deliverables.
• Updating the Sourcing Hub Leader, Global API Technical Managers and other stakeholders on project progress.
• Focusing on the end goals of delivering API technical assessments and problem resolutions with suppliers in the sourcing region.

Job Responsibilities

• Ensure that Apotex achieves the most rapid approval on drug product submission dossiers, the incumbent with be the lead reviewer for sourcing region originated DMFs (open-part and closed-part, when available)
• Ensure that the supplier DMFs conform to the most current requirements of the filing jurisdiction, for example, ICH guidelines (Q3, Q11, M7 etc.), with special attention to the most recent regulator mandated filing requirements
• DMF review must extract and disseminate relevant information needed to assist formulation development, setting of appropriate drug substance specification, and shipping and storage of materials
• Contribute to and manage response plans with manufacturers and Apotex internal groups for DMF deficiency responses, so as to not disrupt application approval timelines or the material supply chain.
• Manage the coordination of NPD and PLCM projects and process/manufacturing site changes between the sourcing region suppliers and GAPI Site Technical teams (and when required, directly with Apotex Analytical Development, Regulatory Affairs, and Formulation Development) to ensure a seamless submission process
• Coordinate the data (OOS investigation, rejection, OOT investigation, CAPA, etc) and information flow between suppliers and GAPI Site Technical teams and/or quality assurance teams for all quality and technical initiatives (Nitrosamine, Allergen, Forced degradation, Stability data, etc) quality related investigations surrounding active ingredients and excipients from the regional hub’s portfolio.
• Working with suppliers, investigate and resolve technical, quality, and regulatory issues related to active ingredients and excipients for NPD, PLCM and Commercial drug products with regard to OOS events, Certificate of Analysis (CofA) discrepancies, documentation for impurities and active standards, manufacturing process changes or site relocations, DMF deficiencies, DMF changes, and specification changes, method alignment
• Coordinate specifications revisions (monograph updates or new project status), as well as industry initiatives, between Apotex and raw material suppliers
• Assist the Global API manufacturer selection process for NPD and PLCM projects through cross-functional communication with the technical teams at the GAPI regional hubs and GAPI site teams
• Contribute information content to GAPI supply databases as required. Maintain the Apotex SharePoint database for DMF and DMF annual updates for the regional hub portfolio
• Perform all other tasks and duties as may, from time to time, be assigned (for example, Confidentiality Disclosure Agreements with suppliers)
• All other duties as assigned.

Job Requirements

• Education:
  • Graduate/ Post Graduate in Science/ Commerce, Economist (Business Administration) or Scientist (Chemistry, Chemical engineering, Pharmacology etc.)
• Knowledge, Skills and Abilities
  • Must possess knowledge of the technical, quality compliance, and regulatory requirements related to the sourcing of APIs.
  • Must possess the ability to provide solutions to a variety of problems of moderate scope and complexity.
  • Ability to read and interpret complex technical documents. Ability to write detailed business correspondence.
  • Ability to work with managers or directors and communicate ambiguous concepts.
  • Excellent communication and interpersonal skills.
  • Strong organizational skills; ability to work independently and manage priorities.
  • Demonstrated knowledge of the generic API new product development process
  • Ability to travel to supplier sites or industry trade conventions when required.
  • Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS Outlook and MS-Excel. Willingness to learn and become proficient with new business software applications as they are introduced to the organization.
• Experience:
  • 8 - 10 years of experience in the pharmaceutical industry.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.