Regulatory Affairs pharmaceutical products –Manager- English

2 weeks ago

Johannesburg, Gauteng, South Africa Genpact Full time

Job Description - Regulatory Affairs pharmaceutical products – Manager - English - Remote Africa (LIF020350)

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

Inviting applications for the role of Regulatory Affairs pharmaceutical products – Manager - English - Remote Africa

You should have a minimum of years of experience in regulatory affairs with knowledge of current regulatory guidelines in Middle and Southern Africa markets.

Responsibilities
  1. In this role, you will be responsible for all local regulatory affairs lifecycle management (LCM) and maintenance activities for assigned products, including but not limited to the following:
  2. Variations (Administrative, Labeling, CMC, Safety, dossier harmonization), renewal, and PSUR: Submission strategy / provide RA Assessment through change management system / CMC Assessment / Timelines / Handling of deficiency letters (DLs) / Management of local RA requirements including implementation tasks (e.g. including grace period for supply continuity), example external compendia. Coordinate artwork changes for submission and implementation (triggered due to LCM activities). Communicates & collaborates effectively with different groups both on the business & IT side, including senior stakeholders – ability to articulate complex scenarios succinctly and targeted to the group.
  3. Update Local PI.
  4. Primary contact for Local Health Authority on delegated products.
  5. Ensure customer success throughout the engagement.
Qualifications we seek in youMinimum Qualifications
  1. Bachelor's degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.
  2. Mandatory Knowledge of EMEA/South Africa regulation and well adherence to the English language.
  3. Registered pharmacist in South Africa.
  4. Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.
  5. Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables.
  6. Demonstrates the ability to independently troubleshoot problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions.
  7. Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
  8. Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.
Preferred Qualifications/Skills
  1. Adhere to our principles and values.

What can we offer?

  1. Attractive salary and benefits such as Medical Aid, Retirement and risk benefits.
  2. Work in a multicultural environment.
  3. Various trainings (technical & soft skills).
  4. Development opportunities in a growing multinational company.

In case Genpact does not respond to your application within 30 days, please consider it was not successful for the current recruitment process for this role.

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation.

#J-18808-Ljbffr

  • Regulatory Affairs Manager for Pharmaceutical Products

    6 days ago

    Johannesburg, Gauteng, South Africa Genpact Full time

    At Genpact, we're shaping the future by delivering outcomes that matter. Our purpose is to create a world that works better for people, and our 125,000+ people across 30+ countries are driven by their innate curiosity and entrepreneurial agility.We're inviting applications for the role of Regulatory Affairs Manager for pharmaceutical products in English,...

  • Regulatory Affairs Manager for Pharmaceutical Products

    2 days ago

    Johannesburg, Gauteng, South Africa Genpact Full time

    Job DescriptionWe are inviting applications for a Regulatory Affairs Manager for Pharmaceutical Products role in our Africa team.About the RoleThis position will be responsible for all local regulatory affairs lifecycle management and maintenance activities for assigned products, including variation submissions, renewals, and post-authorisation safety...

  • Regulatory Affairs pharmaceutical products –Manager- English

    2 weeks ago

    Johannesburg, Gauteng, South Africa Genpact Full time

    Job Description - Regulatory Affairs pharmaceutical products –Manager- English - Remote Africa (LIF020350)Inviting applications for the role of Regulatory Affairs pharmaceutical products –Manager- English - Remote AfricaYou should have minimum years of experience in regulatory affairs with knowledge of current regulatory guidelines in the Middle and...

  • Regulatory Affairs pharmaceutical products –Manager- English

    2 weeks ago

    Johannesburg, Gauteng, South Africa Genpact Full time

    Job Description - Regulatory Affairs pharmaceutical products –Manager- English - Remote Africa (LIF020350)Inviting applications for the role of Regulatory Affairs pharmaceutical products –Manager- English - Remote AfricaYou should have minimum years of experience in regulatory affairs with knowledge of current regulatory guidelines in the Middle and...

  • Regulatory Affairs pharmaceutical products –Manager- English

    2 weeks ago

    Johannesburg, Gauteng, South Africa Genpact Full time

    Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we...

  • Senior Pharmaceutical Regulatory Affairs Professional

    2 days ago

    Johannesburg, Gauteng, South Africa Genpact Full time

    Job SummaryWe are looking for a highly skilled Senior Pharmaceutical Regulatory Affairs Professional - Remote to join our team.About the RoleThis position will be responsible for managing all aspects of local regulatory affairs lifecycle management and maintenance for assigned products.The ideal candidate will have a strong understanding of current...

  • Manager of Regulatory Affairs

    6 days ago

    Johannesburg, Gauteng, South Africa Genpact Full time

    We're seeking a highly experienced Regulatory Affairs Manager to lead our efforts in ensuring the compliance of our pharmaceutical products with regulatory requirements. As a key member of our team, you'll be responsible for managing all aspects of regulatory affairs lifecycle management, including submissions, renewals, and updates.You'll work closely with...

  • Pharmaceutical Affairs and Compliance Manager

    1 week ago

    Johannesburg, Gauteng, South Africa 2705 Roche Products Limited Full time

    Key Challenges and Opportunities:In this role, you will face the challenge of balancing competing priorities while ensuring compliance with complex regulations. However, you will also have the opportunity to shape the future of pharmaceuticals and contribute to the advancement of science.As a Senior Regulatory Affairs Pharmacist, you will be responsible for...

  • Pharmaceutical Affairs Professional

    2 weeks ago

    Johannesburg, Gauteng, South Africa Emporium Full time

    As a Pharmaceutical Affairs Professional at Emporium, you will play a critical role in ensuring the quality and safety of our pharmaceutical products.Job SummaryWe are seeking a highly skilled professional to oversee the development and implementation of regulatory strategies for our portfolio of products.The successful candidate will have extensive...

  • Pharmaceutical Regulatory Consultant

    2 weeks ago

    Johannesburg, Gauteng, South Africa MVG Recruitment Specialists Full time

    Job OverviewA large Pharmaceutical Manufacturing company is seeking a highly skilled Regulatory Affairs Scientist to join their team.This role involves managing and coordinating the compilation and submission of new product applications.The ideal candidate will have a strong background in Regulatory Affairs, with a minimum of 1-2 years' experience in...

  • Regulatory Affairs Scientist

    4 weeks ago

    Johannesburg, Gauteng, South Africa MVG Recruitment Specialists Full time

    Job Title: Regulatory Affairs ScientistLarge Pharmaceutical Manufacturing facility seeks to employ a Regulatory Affairs Scientist. The following applies:Key Responsibilities:Managing and coordinating the compilation and submission of new product applications.Managing and coordinating response to the regulatory authority.Maintain regulatory knowledge of the...

  • Pharmaceutical Regulatory Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Emporium Full time

    At Emporium, we are committed to delivering high-quality pharmaceutical products that meet regulatory standards.Job OverviewWe are seeking a Pharmaceutical Regulatory Specialist to oversee the development and implementation of regulatory strategies for our portfolio of products.The successful candidate will have extensive experience in regulatory affairs,...

  • Regulatory Affairs Manager

    1 week ago

    Johannesburg, Gauteng, South Africa Mvg Recruitment Specialists Full time

    Regulatory Affairs Manager - JohannesburgAbout Mvg Recruitment Specialists:Mvg Recruitment Specialists is a well-established recruitment agency specializing in the pharmaceutical industry. We are currently seeking an experienced Regulatory Affairs Manager to join our team in Johannesburg.Job Responsibilities:The Regulatory Affairs Manager will be responsible...

  • Regulatory Affairs Scientist

    3 weeks ago

    Johannesburg, Gauteng, South Africa Mvg Recruitment Specialists Full time

    Job Title: Regulatory Affairs ScientistCompany: Large Pharmaceutical Manufacturing facility seeks to employ a Regulatory Affairs Scientist.Key Responsibilities:Managing and coordinating the compilation and submission of new product applications.Managing and coordinating response to the regulatory authority.Maintain regulatory knowledge of the various...

  • Regulatory Affairs pharmaceutical products –Manager- English

    5 days ago

    Johannesburg, Gauteng, South Africa Genpact Full time

    Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we...

  • Regulatory Affairs Professional

    1 week ago

    Johannesburg, Gauteng, South Africa Mvg Recruitment Specialists Full time

    Regulatory Affairs ProfessionalAbout Us:Mvg Recruitment Specialists is a leading recruitment agency specializing in the pharmaceutical industry. We are seeking an experienced Regulatory Affairs Professional to join our team.Job Description:This role will be responsible for ensuring timeous initiation and management of the registration process for new product...

  • Regulatory Affairs Professional

    2 weeks ago

    Johannesburg, Gauteng, South Africa MVG Recruitment Specialists Full time

    Large Pharmaceutical Manufacturing facility seeks to employ a Regulatory Affairs Scientist. This role is responsible for managing and coordinating the compilation and submission of new product applications.Key Responsibilities:The ideal candidate will have a BSc or equivalent Science degree in a relevant field and minimum 1-2 years' solid experience in...

  • Regulatory Affairs Specialist

    1 week ago

    Johannesburg, Gauteng, South Africa Emporium Full time

    Emporium OpportunityWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team in Midrand. As a key member of our regulatory team, you will be responsible for managing work streams and reporting on assigned portfolios of products.The ideal candidate will have a strong background in pharmaceutical regulations, with experience in human...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, Gauteng, South Africa MVG Recruitment Specialists Full time

    Regulatory Affairs PharmacistLarge pharmaceutical manufacturing facility seeks to employ a Regulatory Affairs Pharmacist. The following applies:Key Responsibilities:Ensure timeous initiation and management of the registration process for new product submissions.Ensure approval of registration applications of all medicines with the relevant authorities.Ensure...

  • Regulatory Affairs Scientist Johannesburg

    4 weeks ago

    Johannesburg, Gauteng, South Africa MVG Recruitment Specialists Full time

    Regulatory Affairs ScientistLarge Pharmaceutical Manufacturing facility seeks to employ a Regulatory Affairs Scientist. The following applies:Key Responsibilities:Managing and coordinating the compilation and submission of new product applications.Managing and coordinating response to the regulatory authority.Maintain regulatory knowledge of the various...