Sun Pharmaceutical Openings for Senior Manager – Regulatory Affairs – Regulated Market – Biologics/Biosimilars

 Sun Pharmaceutical Industries Ltd Hiring 2022 Bachelors/ Masters  for Senior Manager – Regulatory Affairs – Regulated Market – Biologics/Biosimilars At Gurgaon – R&D . Sun Pharmaceutical Industries Ltd Notification full details below..Interested and eligible candidates can Apply Now.Sun Pharmaceutical Industries Limited (d/b/a Sun Pharma) is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) in more than 100 countries across the globe.

Vacancy details:

  • Post Name: Senior Manager – Regulatory Affairs – Regulated Market – Biologics/Biosimilars
  • Qualification: Bachelors/ Masters 

Job Description: Sun Pharmaceutical Industries Ltd Hiring For Senior Manager – Regulatory Affairs – Regulated Market – Biologics/Biosimilars ! 

Important Details :

  • Location: Gurgaon – R&D
  • Selection ProcessThe selection will be on the basis of Interview.

Roles and Responsibilities

Responsible for providing development support, preparation, review and submission of good quality dossiers (including response to agency deficiencies) for biologics/biosimilars for global markets, thereby enabling faster approvals and timely launch; also ensures business continuity through timely life-cycle management. Also responsible for development and management of team.

  1. New Submissions: Work with Product Development (For Drug products) & other CFT (within and outside R&D) to ensure that sufficient and timely regulatory information and controls are included during design and development of drug products as per country specific regulatory requirements
    1. Provide feedback in terms of document requirements & regulatory filing strategy during development of new DF (Drug Formulation). Review and approve documents on behalf of regulatory.
    2. Preparation/review and submission of good quality dossiers thereby enabling faster approvals and timely launch
    3. Preparation and submission of meeting packages/scientific discussion with Agency related to product development
    4. Anticipate expected deficiencies and prepare mitigation plans
  2. Approval: Prepare and submit timely response to deficiencies enabling approval of products.
  3. Lifecycle Management for approved drug products
    1. Timely preparation and submission of annual reports/renewals/DSUR’s
    2. Evaluation, preparation and submission of changes through variations, supplements etc that impact product supplies
    3. Regulatory Compliance – Ensure timely implementation of regulatory decisions for change management and other activities in DF plants
    4. Ensure reposition of comprehensive product information into central repository
  4. Self and People Development
    1. Awareness of regulatory guidelines, participating and delivering presentations
    2. Provide on job training to Research Associates/Managers

Participate in department initiatives including productivity & benchmarking tools aimed at improving performance 

Global with major focus on United State of America, European Union, Australia/New Zealand and Canada

How to Apply :

Step 1: Click on below link and you will be redirected to  Career Page of Recruiting Company or Career portal.

Step 2. Register on Career Page of the Company or  Career Portal by giving log in credentials and other personal or education details .

Step 3.Upon successful registration .User need to log in with credentials.

Step 4.Once logged in, User need to fill the all relevant personal ,educational  , Work experience details ,attach resume and submit application form.

Click here for notification and Apply

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