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**:

  • Team Member

    2 days ago

    Vikhroli, Mumbai, Maharashtra, India Cipla Full time

    **Division**: - Finance**Department**: - Operations Finance**Sub Department 1**: - SCM Finance**Job Purpose**: Partnering with supply chain function in Global Direct Procurement by a) defining & monitoring targets including cost benchmarking, b) Identifying areas & driving actions to achieve procurement financial goals, c) Track Alternative cost...

  • Team Member

    1 week ago

    Vikhroli, Mumbai, Maharashtra, India Cipla Full time

    **Division**: - IPD**Department**: - IPD**Employment Type**: - Permanent**Job Purpose**: Execute, monitor, report and interpret preclinical, clinical and BABE studies at CROs to support various regulatory submissions within targeted timelines, budgets, quality and regulatory guidelines; identify health hazard and assess risks associated with...

  • Team Member

    2 weeks ago

    Vikhroli, Mumbai, Maharashtra, India Cipla Full time

    **Division**: - IPD**Department**: - IPD**Employment Type**: - Permanent**Job Purpose**: Compile dossier in accordance with regulatory strategy, manage deficiencies, evaluate products and submit tenders to ensure adherence to regulatory requirement for various regulated/international markets within agreed timelines **Accountabilities**: I. Review...

  • Team Member

    2 days ago

    Vikhroli, Mumbai, Maharashtra, India Cipla Full time

    **Division**: - Corporate Affairs **Department**: - Plant Sites **Sub Department 1**: **Job Purpose**: - Cascade corporate affairs agenda at unit locations - Ensure positive engagement with key external stakeholders - Support in obtaining approvals/permissions/ NOCs for the plant location on time - Support in ensuring business continuity at the unit...

  • Hospitality Member

    1 week ago

    Mumbai, Maharashtra, India Team HR Full time ₹ 20,000 - ₹ 24,000 per year

    Job Title: Hospitality MemberSalary : 1000qar - 1150qarLocation : Dubai (Qatar )Department: Food & Beverage / Front of House / EventsReports to: Restaurant Manager / Hospitality Supervisor / Event ManagerJob Summary:The Hospitality Staff member is responsible for providing exceptional customer service to guests, ensuring a welcoming atmosphere, and...

  • Team Member

    2 days ago

    Vikhroli, Mumbai, Maharashtra, India Cipla Full time

    **Division**: - IPD**Department**: Formulation R&D **Employment Type**: - Permanent**Job Purpose**: Execute end to end formula and process development of products following good laboratory practices and continuously monitor its data and quality to have robust a product within the budget, timeline and regulatory standards **Accountabilities**: - Collate...

  • Team Member

    2 weeks ago

    Vikhroli, Mumbai, Maharashtra, India Cipla Full time

    **Division**: - IPD**Department**: Regulatory Affairs **Employment Type**: - Permanent**Job Purpose**: Compile dossier in accordance with regulatory strategy, manage deficiencies, evaluate products and submit tenders to ensure adherence to regulatory requirement for various regulated/international markets within agreed timelines **Accountabilities**: -...

  • Team Member

    2 weeks ago

    Vikhroli, Mumbai, Maharashtra, India Cipla Full time

    **Division**: - IPD**Department**: - IPD**Employment Type**: - Permanent**Job Purpose**: Implement Life cycle management activities for Non-respi products (for US, EU, South Africa, ANZ, WHO, PEPFAR & 150+ countries ) to have Business continuity **Accountabilities**: I. Assess change request across the globe allocated by GL to review, evaluate and...

  • Team Member

    2 weeks ago

    Vikhroli, Mumbai, Maharashtra, India Cipla Full time

    **Division**: - IPD**Department**: - IPD**Employment Type**: - Permanent**Job Purpose**: Implement PAT principles and techniques to processes used during API, formulation development and scale-up to ensure high quality products that consistently deliver the intended performance during technology transfer and manufacturing **Accountabilities**: I....

  • Team Member

    2 weeks ago

    Mumbai, Maharashtra, India Salad Days Full time

    **Team Member, Central Kitchen**: **Company Overview**: Salad Days, established in 2014, is a leader in India's healthy food revolution. We're all about creating gourmet salads and delicious meals that nourish both body and tastebuds. Our mission is to make healthy eating a way of life for everyone in India. We use fresh, high-quality ingredients, operate...