Talent.com
Lead Exec,PLCM

Lead Exec,PLCM

APOTEXMumbai, Maharashtra, India
30+ days ago
Job description

About Apotex Inc.

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.

For more information visit : .

Job Summary

  • Responsible for the product life-cycle management of Apotex products (Toronto) in identified markets.
  • Maintenance of documentation / database records pertaining to approved products in line with systems processes and procedures.
  • Leading and / or coordinating regulatory affairs projects as assigned.
  • Preparation of submission and approval notifications for applications submitted to Regulatory agencies.
  • Support Reporting Manager for planning and execution of trainings to newly joined team members (if any).

Job Responsibilities

  • Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions.
  • Responsible for the preparation and review of quality regulatory PLCM submissions for various markets to ensure timely approval.
  • Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.
  • Accountable for assessment coordination and compilation of deficiency responses in a timely manner.
  • Works with other functional areas to resolve issues related to information for regulatory submissions.
  • Evaluate prepare and review of post-approval supplements to manage the regulatory product life-cycle as applicable.
  • Assessment of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned).
  • Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for PLCM / deficiency response deficiency tracker submission spreadsheet etc.) and ensure accuracy of information.
  • Act as a back-up for team members and support as & when required.
  • Timely communication and follow-up with the respective departments for compilation and submission of PLCM submissions and query responses to meet agreed timeline.
  • Interpret and ensure compliance with SOPs RA policies & procedures and regulatory guidelines. Prepare and / or draft SOPs and regulatory guidelines (as applicable).
  • Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and / or problems.
  • Communicate with external sources such as agents and suppliers to request and / or provide data relevant to submissions.
  • Resolve complex issues relating to submissions.
  • Interpret regulatory guidelines / policies and execute regulatory strategies / activities involved in complex submissions.
  • Support Reporting Manager in developing submission strategies and building technical knowledge within team.
  • Work with Reporting Manager to ensure all department driven projects meet assigned timeline with expected quality standards.
  • Accountable to support overall functioning of team and support Reporting Manager as and when required.
  • Act as a support to Reporting Manager for planning and execution of trainings to newly joined team members (if any).
  • Co-ordinate with third party manufacturers for document requirement for regulatory submissions.
  • Contributes towards the creation and promotion of an environment of teamwork and empowerment built on mutual trust and respect.
  • Works in a safe manner collaborating as a team member to achieve all outcomes.
  • Demonstrate Behaviours that exhibit our organizational Values : Collaboration Courage Perseverance and Passion.
  • Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program Global Quality policies and procedures Safety and Environment policies and HR policies.
  • All other relevant duties as assigned.

    • Job Requirements

  • Education :

    • A Post-graduate / Graduate degree in Chemistry / Pharmacy / Life Sciences.

  • Knowledge Skills and Abilities :

    • Candidate should have knowledge about Post approval change submission requirement and compilation of variation packages for US / CAN / EU / AUS-NZ / ROW markets.

  • Experience :

    • Candidate should have minimum 7 years of experience in US / CAN / EU / AUS-NZ / ROW markets.

    At Apotex we are committed to fostering a welcoming and accessible 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.

    Key Skills

    Administrative Skills,Facilities Management,Biotechnology,Creative Production,Design And Estimation,Architecture

    Employment Type : Full Time

    Experience : years

    Vacancy : 1

    Create a job alert for this search

    Lead • Mumbai, Maharashtra, India

    Related jobs
    • Promoted
    PTC FlexPLM Lead

    PTC FlexPLM Lead

    KMM Technologies, Inc.mumbai, maharashtra, in
    Offshore (India) Position – 1 Resource : .Years of experience implementing FlexPLM for Retail, Footwear and Apparel customers. Experience with all the following areas : .Retail process maturity and the ...Show moreLast updated: 17 days ago
    • Promoted
    Product Engineering Lead, India

    Product Engineering Lead, India

    MarketCrunch AIMumbai, IN
    Full-time | Competitive Compensation + Equity.MarketCrunch AI is redefining how retail investors access and act on investment research. We deliver predictive, AI-powered price targets with the clari...Show moreLast updated: 1 day ago
    • Promoted
    Manager - CRM

    Manager - CRM

    EmeritusMumbai, IN
    Emeritus is committed to teaching the skills of the future by making high-quality education accessible and affordable to individuals, companies, and governments around the world.It does this by col...Show moreLast updated: 28 days ago
    • Promoted
    • New!
    Technical Lead

    Technical Lead

    NAZZTECKalyan-Dombivli, IN
    Experience Required : 8 – 10 Years.Qualification : Engineering (Computer Science).We are looking for a highly experienced. This role involves owning the technology roadmap, ensuring timely delivery, a...Show moreLast updated: 21 hours ago
    • Promoted
    Executive – 3P Manufacturing

    Executive – 3P Manufacturing

    Marico Limitedmumbai, maharashtra, in
    Executive – 3P Manufacturing -.Required Education Qualification : B.Chemical, Oil, or Biochemical Engineering from a top engineering college. Required prior Work Experience : Minimum 5 years in Cosmet...Show moreLast updated: 3 days ago
    • Promoted
    Lead Exec,PLCM

    Lead Exec,PLCM

    ConfidentialMumbai, India
    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 gener...Show moreLast updated: 20 days ago
    • Promoted
    • New!
    Lead Executive Pmo

    Lead Executive Pmo

    Apotex Inc.Thāne, Republic Of India, IN
    Responsible for supporting business processes within Global Business Services, driving program management including but not limited to governance, transition and continuous improvements.Responsible...Show moreLast updated: 9 hours ago
    • Promoted
    Executive

    Executive

    DeloitteThane, Maharashtra, India
    India’s impact on the global economy has increased at an exponential rate and Deloitte presents an opportunity to unleash and realize your potential amongst cutting edge leaders, and organizations ...Show moreLast updated: 14 days ago
    • Promoted
    Project Lead

    Project Lead

    GKB Hitech Lenses Private LimitedThane, IN
    Project Lead- GKB Hi-Tech Lenses Pvt.India’s leading ophthalmic lens manufacturers, we’re driving operational excellence across our manufacturing and service ecosystem. As we expand across multiple ...Show moreLast updated: 16 days ago
    • Promoted
    • New!
    Category Lead

    Category Lead

    NinjacartThane, IN
    Ninjamandi team is a large and diverse team which is trying to solve the problems in the Agri ecosystem with a Platform approach. This growth engine will fuel the next phase of Ninjacart’s journey i...Show moreLast updated: 21 hours ago
    • Promoted
    Sales Director (PLM, ERP or CRM)

    Sales Director (PLM, ERP or CRM)

    JudobiMumbai, Maharashtra, India
    F&B, and consumer goods sectors.We are seeking a dynamic, hands-on.This is a rare opportunity to own the India go-to-market strategy, land marquee accounts, build and lead a high-performing sales t...Show moreLast updated: 14 days ago
    • Promoted
    Technical Lead

    Technical Lead

    JiBe ERPNavi Mumbai, Maharashtra, India
    Position - Technical Lead / Team Manager (Onsite-Navi Mumbai) About JiBe : JiBe is a cloud based fully integrated ERP system for the shipping industry. Our goal is to allow shipping companies to im...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Lead Executive PMO

    Lead Executive PMO

    Apotex Inc.Mumbai, IN
    Responsible for supporting business processes within Global Business Services, driving program management including but not limited to governance, transition and continuous improvements.Responsible...Show moreLast updated: 21 hours ago
    • Promoted
    Sales Director (PLM, ERP or CRM)

    Sales Director (PLM, ERP or CRM)

    ConfidentialMumbai, India
    F&B, and consumer goods sectors.We are seeking a dynamic, hands-on.This is a rare opportunity to own the India go-to-market strategy, land marquee accounts, build and lead a high-performing sales t...Show moreLast updated: 14 days ago
    • Promoted
    • New!
    Lead Generation Executive

    Lead Generation Executive

    Aimsite EventsKalyan-Dombivli, IN
    We’re looking for a driven 𝐁𝟐𝐁 𝐋𝐞𝐚𝐝 𝐆𝐞𝐧𝐞𝐫𝐚𝐭𝐢𝐨𝐧 𝐄𝐱𝐞𝐜𝐮𝐭𝐢𝐯𝐞 to help us identify and connect with high-value prospects. This role is all about building a strong pipeline, openi...Show moreLast updated: 7 hours ago
    • Promoted
    Sector Leader - L&D

    Sector Leader - L&D

    Sales & ProfitThane, IN
    Job Title : Enterprise Sales Manager – L&D Solutions.Learning & Development, HR Tech, Training Solutions, SaaS.B2B Enterprise Sales (New Logos + Key Accounts). We are looking for an experienced.Learn...Show moreLast updated: 1 day ago
    • Promoted
    • New!
    Marketing Lead

    Marketing Lead

    LodhaKalyan-Dombivli, IN
    Role : Lead B2B Brand & Marketing.Lodha Group is building one of India's most diversified B2B / annuity portfolios across High Street Retail, Offices, Malls, Industrial & Warehousing, and Data Centers...Show moreLast updated: 7 hours ago
    • Promoted
    Lead- Marketing Technology

    Lead- Marketing Technology

    5paisaThane, Maharashtra, India
    India's fintech revolution, offering a comprehensive digital platform for retail investors and traders.With a commitment to democratizing financial services, 5paisa provides a suite of products inc...Show moreLast updated: 1 day ago