Regulatory Affairs Manager

3 weeks ago

Midrand, South Africa Servier Full time

.

Job Overview:

As a Regulatory Affairs Manager, you will be responsible for ensuring a thorough and seamless product registration process and dossier maintenance in SEA Cluster. You will ensure that the company complies with all regulations and maintains Servier’s pharmacovigilance requirements.

Duties and Responsibilities:

Lead, manage, and execute strategic direction as the regulatory affairs manager. Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications. Provide input to the regulatory strategy in line with business objectives. Manage and implement safety updates where required. Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations. Handle license renewals with service providers such as SAHPRA and the South African Pharmacy Council (SAPC) Write and develop SOPs in line with Global SOPs. Manage internal and external audits (e.g., Global & SAHPRA) Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation. Manage product complaints and deviations. Maintain regulatory documentation filing system. Ensure regulatory compliance and quality-related records are available and retained. Coordinate product recall or market withdrawal when necessary. Obtain and distribute updated information on domestic and international laws. Report ADR to Global Safety and SAHPRA and follow up on Adverse Drug Reactions (ADRs). Conduct pharmacovigilance training for local staff14. Answer requests from the Regulatory Authority in cooperation with Global Safety Oversee the implementation and maintenance of QMS to ensure compliance with industry standards and regulations. Identify areas for improvement within the quality system and implement corrective and preventive actions. Provide training to staff on quality standards, regulatory requirements, and best practices. Identify areas for improvement within the quality system and implement corrective measures. Maintain and manage quality related documentation, including standard operating procedures (SOPs), work instructions, and quality records. Ensure compliance with environmental regulations and standards at local, national, and international levels. The manager will also manage releases of finished products, customer complaints etc.

Requirements:

Education:

B. Pharm (Bachelor of Pharmacy) and registration with the South African Pharmacy Council (SAPC)

Experience:

Minimum 10 years’ experience in Regulatory Affairs with human medicine and biologicals experience

Skills:

Product registration and dossier maintenance. Pharmacovigilance experience and knowledge of SAHPRA submission portals. Launch procedures for new products QA processes, APQRs, customer complaints. Knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa Microsoft Office Suite proficiency. Familiarity with ZAZIBONA processes and eCTD submissions

Personal Qualities:

Focus Attention to detail Flexibility Planning and organization Communication Teamwork Confidentiality Agility and ability to work in a fast-paced environment Systems knowledge Microsoft office suite including Word, Excel, Power Point at an Intermediate level. Familiar with ZAZIBONA processes Competent and experienced in eCTD submissions.

DISPENSIBLE QUALITIES:

Focus Attention to detail Flexibility Planning and organisation Communication Teamwork Confidentiality Agile and able to work in a fast pace

About Servier: At Servier, we are committed to therapeutic progress to serve patient needs. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages development. We offer tailor-made onboarding journeys, mobility opportunities, quality training, responsible management, and a team spirit-focused workplace.

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognised for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

  • Regulatory Affairs Manager

    2 days ago

    Midrand, Gauteng, South Africa Hire Resolve Full time

    Job Title: Regulatory Affairs ManagerHire Resolve's client is seeking a highly skilled Regulatory Affairs Manager to join their team in Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a seamless product registration process and dossier maintenance. You will ensure that the company complies with all regulations and maintains...

  • Regulatory Affairs Manager

    4 months ago

    Midrand, South Africa Cipla Full time

    **Department**: Regulatory Affairs **Employment Type**: Full-time **Job Purpose**: - Manage submissions to different Health Authorities within the Regulatory Affairs function by ensuring targets are met each financial year - Manage registrations and engagement with the different Health Authorities to ensure targets are met w.r.t. registrations and...

  • Manager - Regulatory Affairs

    2 weeks ago

    Midrand, South Africa PSG Konsult Full time

    The Manager for Regulatory Affairs reports directly to the Head of Public Policy and Regulatory. The role is responsible to manage all regulatory and compliance developments and affairs for PSG ensuring the group's understanding and adherence to relevant financial regulations, laws, and industry guidelines. The position plays a key role in engaging senior...

  • Regulatory Affairs Specialist

    1 day ago

    Midrand, Gauteng, South Africa Hire Resolve Full time

    Regulatory Affairs Manager Job DescriptionHire Resolve's client is seeking a highly skilled Regulatory Affairs Manager to join their team in Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a seamless product registration process and dossier maintenance.Key Responsibilities:Lead and manage the regulatory affairs function to...

  • Regulatory Affairs Manager

    3 weeks ago

    Midrand, South Africa The Globevest Group Full time

    Position: Regulatory Affairs Manager Salary: Market related Location: Midrand Job type: Permanent Industry: Pharmaceutical Reference Number: RDT.S.RAM.16092024 COMPANY DESCRIPTION: Our client is an international pharmaceutical company with offices in Midrand and they are looking for a Regulatory Affairs Manager to join their team as soon as possible. JOB...

  • Regulatory Affairs Director

    1 week ago

    Midrand, Gauteng, South Africa Jordan HR Full time

    Jordan HR is seeking a highly skilled and experienced professional to fill the role of Head of Regulatory Affairs Manager. The ideal candidate will possess a strong background in pharmaceutical regulatory affairs and have a proven track record of leading cross-functional teams to drive collaboration, innovation, and operational excellence. Key...

  • Regulatory Affairs Specialist

    2 weeks ago

    Midrand, Gauteng, South Africa Globevest Group Full time

    Regulatory Affairs ManagerCompany Overview:Globevest Group is an international pharmaceutical company with a strong presence in Midrand. We are seeking a highly skilled Regulatory Affairs Manager to join our team.Job Summary:The Regulatory Affairs Manager will be responsible for ensuring compliance with all regulations and maintaining the company's...

  • Regulatory Affairs Specialist

    4 days ago

    Midrand, Gauteng, South Africa The Globevest Group Full time

    Regulatory Affairs Manager Job DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at The Globevest Group. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and maintaining a seamless product registration process.Main Responsibilities:Lead the development and...

  • Regulatory Affairs Manager

    2 weeks ago

    Midrand, Gauteng, South Africa Healthcare Businesswomen's Association Full time

    Job DescriptionJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at the Healthcare Businesswomen's Association. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to support product registration and clinical trials.Key...

  • Regulatory Affairs Specialist

    2 weeks ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.About the RoleWe are looking for a seasoned professional with expertise in regulatory affairs, particularly in human medicines, including complementary medicines and medical devices. The successful candidate will be...

  • Regulatory Affairs Manager

    3 days ago

    Midrand, South Africa Hire Resolve Full time

    Hire Resolve's client is actively seeking a Regulatory Affairs Manager to join their team in Midrand, Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a thorough and seamless product registration process and dossier maintenance. You will ensure that the company complies with all regulations and maintains pharmacovigilance...

  • Regulatory Affairs Director

    2 weeks ago

    Midrand, Gauteng, South Africa The Globevest Group Full time

    Job Title: Regulatory Affairs ManagerJob Type: PermanentIndustry: PharmaceuticalLocation: MidrandJob Description:Key Responsibilities:Lead Regulatory Affairs: Develop and implement regulatory strategies to ensure compliance with relevant laws and regulations.Product Registration: Oversee the registration process for new products, ensuring all necessary...

  • Regulatory Affairs Specialist

    1 day ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Key Responsibilities:Develop and implement regulatory strategies for human medicines, including complementary medicines and medical devices.Manage end-to-end regulatory activities, ensuring compliance with Good Manufacturing...

  • Regulatory Affairs Specialist

    1 week ago

    Midrand, Gauteng, South Africa The Globevest Group Full time

    Regulatory Affairs ManagerOur client, a leading international pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join their team in Midrand. As a key member of the team, you will be responsible for ensuring compliance with all regulations and maintaining the company's pharmacovigilance requirements.Main Responsibilities:Lead...

  • Regulatory Affairs Specialist

    3 weeks ago

    Midrand, Gauteng, South Africa Emporium Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.Key ResponsibilitiesRegulatory ComplianceManage work streams for- and report on the...

  • Regulatory Affairs Specialist

    13 hours ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for pharmaceutical products.Key Responsibilities:Manage work streams for- and...

  • Regulatory Affairs Specialist

    3 days ago

    Midrand, Gauteng, South Africa Emporium Human Capital Full time

    Job Title: Regulatory Affairs PharmacistEmporium Human Capital is seeking a highly skilled Regulatory Affairs Pharmacist to join our team.Key Responsibilities:Manage work streams for- and report on the assigned portfolio of products, ensuring timely and accurate submissions to regulatory agencies.Establish regulatory priorities and allocate resources and...

  • Head of Regulatory Affairs Director

    1 week ago

    Midrand, Gauteng, South Africa MNA Recruitment (Pty) Ltd Full time

    Head of Regulatory Affairs Job DescriptionMNA Recruitment (Pty) Ltd is seeking a highly skilled and experienced Head of Regulatory Affairs to join their team. The successful candidate will be responsible for leading the Regulatory Affairs Division and overseeing the development and delivery of a fully integrated regulatory strategy for the business.Key...

  • Regulatory Affairs Specialist

    1 week ago

    Midrand, Gauteng, South Africa The Globevest Group Full time

    Regulatory Affairs ManagerOur client, a leading international pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join their team in Midrand. As a key member of the team, you will be responsible for ensuring compliance with all regulations and maintaining the company's pharmacovigilance requirements.Main Responsibilities:Lead...

  • Head of Regulatory Affairs

    1 week ago

    Midrand, South Africa MNA Recruitment (Pty) Ltd Full time

    A prominent Pharmaceutical Company is seeking a Head of Regulatory Affairs Division to join their team.The Head of Regulatory Affairs holds ultimate responsibility for the division’s regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business. The Head of Regulatory Affairs will additionally be...