Novartis Chemistry Job Vacancy – Pharma & Chemistry DRC Manager

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

Minimum requirements

  • 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.

Job Description

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:

  • 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.

Apply Online

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