Regulatory Affairs pharmaceutical products –Manager

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 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 - On site Johannesburg
You should have minimum Relevant years of experience in regulatory affairs with must knowledge of current regulatory guideline in South Africa Market.

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): Submission strategy / provide RA Assessment through change management system / CMC Assessment / Timelines / 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

• Bachelor's 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

• Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously

• 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

• Demonstrates the ability to independently solve trouble shoot 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;

  • Regulatory Affairs Pharmaceutical Products –Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa Genpact Full time

    Job Description - Regulatory Affairs pharmaceutical products –Manager - English - On site Johannesburg (LIF Regulatory Affairs pharmaceutical products –Manager - English - On site Johannesburg - LIF016395 Genpact (NYSE:G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+...

  • Head of Regulatory Affairs, Responsible Pharmacist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Takeda Pharmaceutical Full time

    Title:_ Head of Regulatory Affairs, Responsible Pharmacist Location:_ __Johannesburg, South Africa_ _office._ Field: Regulatory and Quality_About TakedaAt Takeda we strive to broaden access to treatment and enhance standards of care for people wherever they live. We focus on sustainably strengthening local health systems in low- and middle-income countries...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Johannesburg, Gauteng, South Africa JorDan Human Resources Full time

    Permanent CT00417 Medical, Pharmaceutical & Nursing Gauteng, JHB Northern Suburbs R R 58000 Monthly Cost To Company (Standard Benefits ) Pharmaceutical Production Client in JHB North in need of a Regulatory Affairs Pharmacist, to ensure legal compliance with the relevant Medicine Regulatory Authorities (Country Specific where applicable) Ensure compliant...

  • Head of Regulatory Affairs

    2 weeks ago

    Johannesburg, Gauteng, South Africa PSM Personnel Full time

    Head of Regulatory Affairs Pharmacist ~ RegulatoryJohannesburg North-GautengWe are looking for the Head of Regulatory Affairs to join our clients team of experts, a leader who has managed people for a minimum of 5 years. Someone who will oversee the development and delivery of a fully integrated regulatory strategy for the business. In this role, you will...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Six Sense Full time

    Gauteng, JHB - Eastern Suburbs Annually Cost To Company (Market related)Well established Pharmaceutical business seeking to appoint a Regulatory Affairs Pharmacist.Minimum Requirements: Bachelor's degree in Pharmacy, registered with the South African Pharmacy Council MSc, MBA or PhD may be an advantage Experience in regulatory affairs, preferably in human...

  • Head of Regulatory Affairs

    2 weeks ago

    Johannesburg, Gauteng, South Africa Unique Personnel Full time

    Job Number 71851Job Type PermanentJob Title Head of Regulatory AffairsComputer Skills Ms OfficeIndustry ManufactureCity Johannesburg (Incl. Northern Suburbs)Province GautengReporting To Managing Director - company OTCJob Purpose The Head of Regulatory Affairs holds ultimate responsibility for the company OTC division's regulatory activities and oversees the...

  • Head of Regulatory Affairs

    2 weeks ago

    Johannesburg, Gauteng, South Africa Ultra Personnel Full time

    Essential Skills and Experience RequiredQualifications: B. Pharm Degree Registration with South African Pharmacy Council, MS or PhD in life sciences or related field is required.A minimum of 8 years of pharmaceutical regulatory experience is a prerequisite with excellent knowledge and understanding of the current pharmaceutical industryMinimum of 5 years in...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Johnson & Johnson Full time

    REGULATORY AFFAIRS PHARMACISTLocation: GautengContract: PermanentThe responsibilities & the impact YOU will have:SummaryTo effectively complete all required Regulatory tasks relating to product registrations and dossierlifecycle maintenance for products the local operating company (LOC) has regulatory responsibility and to ensure these tasks are performed in...

  • Senior Regulatory Affairs Pharmacist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Six Sense Full time

    Gauteng, JHB - Eastern Suburbs Annually Cost To Company (Market related)Well established pharmacuetical business seeking to appoint Senior Regulatory Affairs Pharmacist.SKILLS & QUALIFICATIONS: Bachelor's degree in Pharmacy, registered with the South African Pharmacy Council MSc, MBA or PhD may be an advantage. Experience in regulatory affairs, preferably in...

  • Regulatory Affairs Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa Unique Personnel Full time

    Job Number 72786Job Type PermanentJob Title Regulatory Affairs ManagerComputer Skills Ms OfficeIndustry ManufactureCity Johannesburg (Incl. Northern Suburbs)Province GautengReporting to Head: Regulatory AffairsJob purpose: Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners...

  • Regulatory Affairs

    2 weeks ago

    Johannesburg, Gauteng, South Africa LA Medical Recruitment Specialists Full time

    Bachelor of Pharmacy Degree, Postgraduate (PHD/MBA) an advantage. Qualification in Medical Device & EHS Regulations preferred. 3 years experience in Regulatory & Quality Assurance in Pharma or Medical device environment. 3 -5 years experience at executive management level.Knowledge of medical and pharmaceutical products and services; legal requirements...

  • Senior Regulatory affairs pharmacist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Curiska Full time

    JOB TITLE: Regulatory Affairs PharmacistCOMPANY: Pharmaceutical CompanyDESCRIPTION: Join our team as a Regulatory Affairs Pharmacist to ensure a smooth product registration process and compliance with all regulations. Your role involves overseeing regulatory documentation, managing safety updates, and maintaining pharmacovigilance requirements.DUTIES AND...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Johannesburg, Gauteng, South Africa MNA Recruitment Full time

    A global pharmaceutical company has a vacancy for a Regulatory Affairs Pharmacist to co-ordinate, project control and provide regulatory support for Central, East Africa and Mauritius countries.Key Responsibilities: Keeping abreast of regulatory requirements in Central, East Africa and Mauritius countries. Ensure the completion of submissions/ variations...

  • Regularity Affairs Pharmacist

    2 weeks ago

    Johannesburg, Gauteng, South Africa RPO Recruitment Full time

    RPO Recruitment is a trusted recruitment agency specializing in finding top talent in the field of regulatory affairs within the pharmaceutical industry. Our client, a leading pharmaceutical company, is seeking a Regulatory Affairs Pharmacist to join their team.As a Regulatory Affairs Pharmacist, you will play a vital role in ensuring compliance with...

  • Regulatory Affairs Pharmacist Sa

    2 weeks ago

    Johannesburg, Gauteng, South Africa AstraZeneca Full time

    ABOUT ASTRAZENECAAstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious disease. But we're more than one of the world's leading pharmaceutical companies.At AstraZeneca we're dedicated to being a Great Place to Work....

  • Head of Regulatory Affairs, Responsible Pharmacist

    2 weeks ago

    Johannesburg, Gauteng, South Africa ARIAD Full time

    Head of Regulatory Affairs, Responsible Pharmacist:Johannesburg, GautengJob ID R0118346Category Research & DevelopmentSubcategory Research & DevelopmentBusiness Unit Global Portfolio DivisionJob Type Full time Title:_ Head of Regulatory Affairs, Responsible Pharmacist Location:__Johannesburg, South Africa__office._ Field: Regulatory and Quality_About...

  • Senior Regulatory Affairs Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa Six Sense Consulting Full time

    Minimum Requirements: B Pharm or Related Scientific Degree M Pharm an advantage but not a requirement Regulatory Affairs Pharma Industry 10+ years experience, of at least 5 years management experience SAPC Registered PharmacistKey Knowledge and Skills required: Relevant Acts, Regulations, and guidelines that governs the Pharmaceutical Industry Regulatory...

  • Head of Regulatory Affairs, African Cluster

    2 weeks ago

    Johannesburg, Gauteng, South Africa AstraZeneca Full time

    Do you have expertise in and a passion for science _and innovation through medicine, working in Regulatory Affairs leading a regulatory team to long-term success, and creating value for our patients through timeous submissions, accelerated approval and regulatory authority relationship and capability building? If so, AstraZeneca might be the one for...

  • Regulatory Affairs Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa Thermo Fisher Scientific Full time

    PPD, part of Thermo Fisher Scientific, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve healthWe are vital links between an idea for a new medicine and the people who need it.We are...

  • Regulatory Affairs Pharmacist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Unique Personnel Full time

    Job Number 72665Job Type PermanentJob Title Regulatory Affairs PharmacistComputer Skills Ms OfficeIndustry ManufactureCity Johannesburg (Incl. Northern Suburbs)Province Gauteng Reporting To Regulatory Affairs Manager / Senior RA PharmacistJob Purpose To Support the Regulatory Affairs team with electronic compilation, documentation control and publishing of...