Regulatory Affairs pharmaceutical products –Manager- English - Remote Africa

Genpact; Johannesburg; Remote; ZAR 300 000 - 600 000; Full time

Job summary

This innovative firm is seeking a Regulatory Affairs Manager to oversee the lifecycle management of pharmaceutical products in Southern Africa. The role involves ensuring compliance with local regulations, managing submissions, and collaborating with various stakeholders to drive customer success. Join a diverse team dedicated to creating impactful solutions and enjoy attractive benefits, including medical aid and development opportunities. If you are passionate about regulatory affairs and thrive in a dynamic environment, this position offers the chance to make a significant difference in the pharmaceutical industry.

Benefits

Medical Aid

Retirement benefits

Training opportunities

Multicultural work environment

Qualifications

• Bachelor’s degree in relevant field with experience in regulatory affairs.
• Registered pharmacist in South Africa with knowledge of local regulations.

Responsibilities

• Manage local regulatory affairs lifecycle for assigned products.
• Coordinate artwork changes and communicate with stakeholders.
• Ensure customer success and compliance throughout engagement.

Skills

Regulatory Affairs

Knowledge of EMEA/South Africa regulation

Time Management

Effective Communication

Problem Solving

Education

Bachelor’s degree in Pharmacy, Medicine, Chemistry, or related Life science

Registered pharmacist in South Africa

Job description

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 minimum years of experience in regulatory affairs with must knowledge of current regulatory guidelines in Middle and Southern Africa Markets.

Responsibilities

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:

1. 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.
2. Coordinate artwork changes for submission and implementation (triggered due to LCM activities).
3. 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.
4. Update Local PI.
5. Primary contact for Local Health Authority on delegated products.
6. Ensure customer success throughout the engagement.

Qualifications We Seek In You!

Minimum 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 adheres of 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 solve trouble shoot 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. Enthusiasm & confidence.
2. Adhere to our principles and values.
3. Time Management skills.

What Can We Offer?

Attractive salary and benefits such as Medical Aid, Retirement and risk benefits.

Work in a multicultural environment.

Various trainings (technical & soft skills).

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. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.

Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.