Team Member - Regional Regulatory Affairs
Company: Cipla
Mumbai, Maharashtra, India (On-site)
Full-time · Entry level
10,001+ employees · Pharmaceuticals
Job Location - Vikhroli
Division - IPD
Department -IPD
Employment Type - Permanent
Job Description -
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
I. Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time
II. Submit post approval variations for changes that improves productivity, cost-effectiveness, quality of the product by reviewing, collating, compiling the variation application to meet the delivery within timelines and maintain Product Marketing Authorization, Renewals/Sunset clause to ensure continuous validity of marketing authorisations.
III. Maintain, and update product dossier as required to meet changes in Cipla̢۪s internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements
IV. Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database.
V. Provide Regulatory support throughout the life cycle of the product for smooth functioning
VI. Provide the information on the suitability and availability of dossier for out-licensing and in-licensing
VII. Check with regulatory authorities (EU, NZ & TGA) for submission activity and approval status for submission done
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
- 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.)
About Us
At Cipla, we constantly work towards ensuring access to high quality and affordable medicines to support patients in need. Which is why, we have been trusted by health care professionals and patients across geographies for the last 8 decades.
Cipla, as an organisation has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, we are deepening our presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world.
Careers at Cipla
Our highly skilled global workforce, with their unwavering commitment to excellence, has been a critical pillar of Cipla’s success story. We achieve our shared goals and organisational objectives by strategically focusing on attracting, retaining and developing the correct talent mix with diversity in relation to gender, age, expertise and geographical heterogeneity.
We at Cipla are inspired by our purpose of 'Caring for Life' and strive to extend this philosophy to our associates and their families. Our endeavour is to build a high-performance and meritocratic work culture with care as the cornerstone.