Novartis Chemistry Job Vacancy – Pharma & Chemistry DRC Manager
M.Pharma Manager job openings. Pharmaceutical Jobs. Applications are invited for the post of manager @ Novartis. Career @ Novartis Pharma job opening .vacancy at Novartis. Interested candidates may apply online. Novartis Pharma jobs 2019. Check out all the details on the same below:
Job Title: Manager – Development Regulatory Centers (DRC)
Job Id: 283546BR
- What you’ll bring to the role:
Science degree (Pharmacy, Chemistry,). English, other languages are an asset.
Relevant work experience: 5 to 8 years – Minimum 5 years Regulatory Affairs experience or similar pharmaceutical regulated environment.
- Original submission experience with oral dosage forms is required.
- Excellent communication skills. High level of organizational skills. Positive attitude, problem-solving mindset.
- Extensive hands-on knowledge with CTD Module 2, 3 and 5.
- Good knowledge of the business process and project management in the development of generics.
- Solid knowledge of ICH, EMA, US FDA, ROW guidelines and regulatory procedures.
The primary responsibility of this position is to ensure:
1. All assigned projects have clearly defined regulatory strategies in order to optimize the development work and time to market
2. Regulatory filings/dossiers are prepared and/or reviewed as per established development
3. Timely regulatory approval is obtained by relevant Health Authorities.
- Your responsibilities include, but are not limited to:
Elaborates global regulatory strategies for new product development.
- Ensures that all strategies are scientifically sound and in accordance with relevant regulatory requirements.
- Participate in project/product-related discussions and provides in-depth strategic, scientific and RA input, for CMC or procedural aspects of given project.
- Ensure planning and proper organization of activities in line with the overall project plan and project milestones.
- Ensure no delays in submission approval timelines or “first to file” opportunity losses due to gaps in the regulatory strategy and plans.
- Responsible for preparation and review regulatory submissions (e.g. ANDS, ANDA, SNDS, NDA) and responses to Health Authority queries.
- Compile/write high quality project/product specific regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements.
- Continuously improves the quality of dossiers sent to the regulatory authorities ensuring optimal review timelines. Training and regulatory oversight.
- Search, analyze, interpret and implement international regulations, guidelines and policies as they pertain to Sandoz products.
- Transfer new regulatory related information by preparing internal workshops for training of both DRC and SDC personnel.
- Provide regulatory training and coaching to the DRC associates, as needed.
- Participate in the development and implementation of standard operating procedures.
- Act as the point of contact for Global Regulatory Affairs initiatives/programs.
- Provides support and coordinates with relevant SDC team members. Provide support for health authority inspections.
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