Team Member

2 days 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 categorize the change as per regulatory guidelines to meet launches, commercial needs and compliance
II. Prepare variation packages for modules 2 to 5 and deficiency response across the globe to support commercial launches, on-going commercial and regulatory compliance.
III. Prepare annual report (US) as per schedule to meet regulatory compliance for business continuity.
Prepare WHO requalification dossier to maintain product licence for business continuity.
IV. Compile re-registration dossier to maintain product licence for business continuity.
V. Maintain and update product database for easy retrieval and status tracking

**Education Qualification**:
Minimum Graduate in Pharmacy or Life Sciences

**Relevant Work Experience**:
5 years in the field of Regulatory Affairs/ Quality Assurance/ Quality control/ Manufacturing/ Analytical Development/ R&D

**Competencies/Skills**:

- Communication Skills (clarity of thought, comprehension)- Likely potential for growth- Job / Product / Technical Knowledge / Pharma domain knowledge- Presentation & Interpersonal skills (If applicable)- Managerial or People Management skills- Safety awareness (If applicable)- Relevance of Previous Experience- Comprehension, Analytical & Problem solving abilities- Productivity & Result Orientation (If applicable)- Attitude- Qualification fitment- Sales drive (If applicable)- Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)**Job Location**:
Vikhroli

**Shift Hours**:


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