Job Opportunity in Algeria: Regulatory Affairs Manager at Novartis

Deadline : 15 Apr 2020

Nonprofit organization: Novartis

Specialities: Medical Sciences

Study level: Undergraduate

Viewed 187 times

Job Opportunity in Algeria: Regulatory Affairs Manager at Novartis

Novartis is looking for a qualified Regulatory Affairs Manager to join the team in Algeria for 2020, to provide effective regulatory for new product registration, regulatory maintenance, and regulatory intelligence activities.

Responsibilities:

New product registration:

  1. Coordinate with Local business on priority and registration strategy of NCEs.
  2. Implementing the registration of priority / new products as per the agreed yearly objectives, evaluate, prepare and submit drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favorable outcome for registration and pricing.
  3. Coordinate with Regional Brand Regulatory Managers team to ensure having the registration requirements on time, hence fast submission / approval of new products.
  4. Update Business and key stakeholders on registration status of NCEs. 

Regulatory maintenance:

  1. Preparation, submission and follow up of regulatory files.
  2. Ensure fast implementation/ correct consignments.
  3. Ensure speedy approvals from Health Authorities.
  4. Update local registration files.
  5. Ensure clear and timely communication with internal and global stakeholders.
  6. Update and accurate tracking of archives and systems. 

De-registration /Divestment:

  1. Initiate de-registration of pruned products without affecting the existing stock, coordinating with involved stakeholders.
  2. Update local registration files with submission and/or confirmation from HA for the de-registration
  3. Ensure clear and timely communication with internal and global stakeholders.
  4. Provide necessary supports to the responsible parties of the acquired companies for the Novartis products divested to them.
  5. Provide necessary maintenances to the divested products until the divestment process is completed.
  6. Necessary follow-ups until the Marketing Authorization of the divested product is transferred to the new company.

Logistic:

  1. Ensure optimal supply regulatory process.
  2. Address manufacturing site queries concerning shipment approval/authorizations/pre license sale.
  3. Coordinate with Logistics/ chain supply/ Artwork teams and manufacturing site to obtain valid artworks and implementation dates.
  4. Coordinate with Logistics/ chain supply/ Artwork teams and manufacturing site to ensure that the registered product specifications are compliant and being imported to the country. 

Quality assurance/compliance:

  1. Support QA for batch release.
  2. Validation of promotional tools.

Measure of Success:

Timely registration of new drug products.

Effective regulatory intelligence activities and implementation of HA management plans.

100% regulatory compliance for DRAGON database.

Minimum requirements:

  1. Degree in Pharmacy.
  2. Arabic, English & French.
  3. 3-4 years practical experience in regulatory affairs dealing with a wide variety of registration projects and issues.
  4. Excellent English required (oral and written).
  5. Effective planning, organizational, and interpersonal skills.
  6. Excellent negotiation skills. 
  7. Computer literacy.

About Novartis:

The purpose of Novartis is to reimagine medicine to improve and extend people's lives. It uses innovative science and technology to address some of society's most challenging healthcare issues. It discovers and develops breakthrough treatments and find new ways to deliver them to as many people as possible.

See more available Master’s scholarships on Mina7

See more available jobs on Mina7

Discover available opportunities in Algeria

Do not forget to mention Mina7 in your application.

Host Country: Algeria

STAY IN TOUCH

Mina7 apps

Choose your study destination


Choose the country you wish to travel to study for free, work or volunteer

Featured tags

forsa

Important News and Guides To Study Abroad