Team Member

4 days ago

Vikhroli Mumbai Maharashtra, India Cipla Full time

**Division**:

- IPD**Department**:

- IPD**Employment Type**:

- Permanent**Job Purpose**:
Submit product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products life-cycle

**Accountabilities**:

- Support Group leader -ANZ in providing input and support for regulatory strategies in development product and dossier compilation to meet the timeline and in line with organizational objectives
- Support Due diligence in ANZ region and drive smooth execution of due diligence’s in collaboration with key stake holders.
- Thorough understanding of TGA and Medsafe guidelines and requirements.
- Ensure the review and submission of dossiers in accordance to the health authority requirements - TGA and Medsafe
- Maintain files/databases/trackers to reflect up to date registration, change control and post approval changes and update central database for new submissions in ANZ.
- Maintain current registered/commercialized products: RA table preparation, Artwork/SPMS review, Product list updation for Technical agreement
- Managing third party projects - Due diligence in ANZ region and drive smooth execution of due diligence’s in collaboration with key stake holders.
- Handling Authority/Customer/Consultant queries
- Ensure partnering, collaboration, interactions and co-ordination within International Regulatory, Regulatory operations (Dossier and Life cycle management team), API and other functions including Formulation and Analytical Development, Business teams, Project Management, QA, Mfg. units etc.
- Building relationship with other stake holder and liase directly with business and support ANZ group leader to organization goal.
- Support group ANZ in providing timely update/escalation for top priority project
- Attending training sessions conducted by GL's/TL's on regulatory requirements, working and handling on internal software systems such as Cipdox, SAP, Documentum, Extedo, trackwise etc. implementing the same for their day to day activity.

**Education Qualification**:
B.Pharmacy, M. Pharm, Bsc or MSc

**Relevant Work Experience**:
Minimum 5 years' experience in regulatory activity in pharma industry preferably worked for same region/authority

**Competencies/Skills**:

- Collaborate to Succeed- Innovate to Excel- Perform with Accountability- Lead with Empathy- Act with Agility- Strong Domain Knowledge- People Management**Job Location**:
Vikhroli

**Shift Hours**:

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