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Job Description:
Position: Life Cycle Management Specialist
Division: IPD
Department: IPD
Employment Type: Permanent
Job Purpose:
As a Life Cycle Management Specialist for Non-respiratory products (for US, EU, South Africa, ANZ, WHO, PEPFAR & 150+ countries), your main responsibility is to ensure business continuity through effective implementation of life cycle management activities.
Accountabilities:
- Assess change requests from across the globe, allocated by the Global Lead (GL), to review, evaluate, and categorize the changes in accordance with regulatory guidelines. This is to meet product launches, commercial requirements, and compliance standards.
- Prepare variation packages for modules 2 to 5 and deficiency responses across the globe, supporting commercial launches, ongoing commercial activities, and regulatory compliance.
- Prepare the annual report for the US market as per the prescribed schedule to ensure regulatory compliance and uninterrupted business operations.
- Create WHO requalification dossiers to maintain product licenses and ensure business continuity.
- Compile re-registration dossiers to sustain product licenses and enable business continuity.
- Maintain and regularly update the product database for easy retrieval and status tracking.
Education Qualification:
Minimum Graduate in Pharmacy or Life Sciences.
Relevant Work Experience:
You should have at least 5 years of experience in the field of Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Analytical Development, or R&D.
Competencies/Skills:
- Excellent communication skills, including clarity of thought and comprehension.
- Strong potential for growth and career development.
- In-depth knowledge of the pharmaceutical domain and product-specific technical knowledge.
- Effective presentation and interpersonal skills (if applicable).
- Managerial or people management skills.
- Safety awareness (if applicable).
- Previous experience that aligns with comprehension, analytical and problem-solving abilities.
- Result-oriented and productive approach (if applicable).
- Positive attitude and willingness to adapt.
- Relevant qualifications and experience for the role.
- Sales drive (if applicable).
- Possession of desirable personality traits (e.g., individualistic/team player, outspokenness, maturity level, etc.).
Job Location: Vikhroli
How to Apply
To apply for this Cipla LCM Team Member Post, please click on the below link.
About Cipla
Cipla, a renowned pharmaceutical company committed to providing accessible healthcare solutions, is seeking dynamic individuals to join their manufacturing division as Junior Officers. This position offers a unique opportunity to contribute to the production process and ensure the highest standards of quality and safety.