Title:  Sr. Officer

Job Title:

Sr. Officer/Executive

Business Unit:

Regulatory & Business Continuity

Job Grade

G12A/G12B

Location:

Gurgaon

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

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List of Responsibilities/Job Functions:

• File Products on time in Ectd - OCR, Bookmarking and Hyperlinking on Adobe acrobat for eCTD submissions and ECTD Support.
• Track wise Site Coordination (Regular Track wise Site coordination by maintaining entire track wise UAM's lifecycles on our track wise portal. (Providing access, updating access rights and closure of track wise account).
• Other eCTD submissions and support (including life cycle management response to queries, annual reports, Variations, renewals etc.) - Processing Files (OCR, Bookmarking and Hyperlinking on Adobe acrobat) for other eCTD submissions, working on other eCTD submissions and support (including life cycle management Annual reports, Amendments/Applications/Supplements, Variations, Response to queries, renewals etc.)
• Updation of LID status, Output replica trackers/Products Product history sheets, USFDA Submission tracker, US Annual Report tracker, Post Approval Supplement Tracker.
• Daily report (EU/AU) Release, AU DR Reposition - Consolidation, reposition of related document in shared folder and release of daily report to all identified stakeholders and Australia Daily Report Reposition and PHS updating work (Reposition of all DR attachments at AUS online SharePoint and updating PHS).
• SOP Revision activities on EDMS and CCR Creations in Track wise.

Competencies Required:

• eCTD Publishing & Submission Management
• Document Publishing & Processing
• Understanding of USFDA, EU and other health authority submission requirements.
• Track Wise Administration
• Document Management Systems (EDMS)

Travel Estimate

Job Requirements

Educational Qualification –

B.Sc. or B. Pharma

Experience –

Tenure:  2- 5 Years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).