Team Member - CDT (68315)

Requisition ID 68315

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

1. Compilation and submission of high quality China/Europe/Brazil dossiers, respecting agreed CMC regulatory strategy, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
2. Identify the required documentation for submissions and negotiate the delivery of documents in accordance with project timelines.
3. Collecting data from various departments for preparation of dossiers to support the product registration.
4. Review and approval of various CMC documents.
5. Evaluation, compilation, review and submission of high quality deficiency response during registration and ensuring timely submission of deficiency response.

Education Qualification

Graduate/Post Graduate in Pharmacy or Life Sciences

Relevant Work Experience

Minimum 3-4 years’ experience in China/EU/Brazil/Australia/UK regulatory affairs for drug products (Pre-approval)

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.)

Interested candidates Click on below link Apply Online and you will be redirected to Career Page of Company or Career url.

Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control and depression; other medical conditions.