Regulatory Affairs pharmaceutical products Manager- English - Remote Africa
Regulatory Affairs pharmaceutical products Manager- English - Remote Africa
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1 Vacancy
Job Description
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 guideline 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:
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
Update Local PI
Primary contact for Local Health Authority on delegated products
Ensure customer success throughout the engagement
Qualifications we seek in you!
Minimum Qualifications
Bachelors degree preferably in Pharmacy Medicine Chemistry or related Life science discipline required with relevant experience in the pharmaceutical industry.
Mandatory Knowledge of EMEA/South Africa regulation and well adheres of English language
Registered pharmacist in South Africa
Effective time management and organizational skills to efficiently manage multiple timesensitive assignments simultaneously
Demonstrates deep understanding of the business value of quality and compliance and the implications and risks of noncompliance. Adjusts behaviors to drive high quality deliverables
Demonstrates the ability to independently solve trouble problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions
Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
Flexibility to adapt to a changing environment keeping current with new and updated processes and procedures
Preferred Qualifications/ Skills
Enthusiasm & confidence
Adhere to our principles and values.
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 . 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.
Required Experience:
Manager
Employment Type
Full-Time
