Regulatory Affairs Clinical Trials

2 weeks ago


Sandton, South Africa Pfizer Full time

**Job Title: Regulatory Affairs Clinical Trials Pharmacist/Specialist**
**Business Unit/Division**:Regulatory Affairs

**Job Type Classification**:Permanent

**Location - Town/City**:Sandton

**Location - Province**:Gauteng

**Location - Country**:South Africa

**Key Performance Outputs**:

- Enhancing and managing relationships with regulatory health authorities (HAs) and Boards of Health (BoHs).
- Understand local regulations, guidelines and developing trends in the local regulatory environment. Leverage regulatory knowledge to anticipate barriers and recommend alternative approaches in line with local policies and procedures.
- Liaise with clinical research project managers and local clinical oversight colleagues to seek to understand clinical research programmes as required. Assist as applicable with any regulatory related country feasibility questions and regulatory intelligence.
- Participation in discussions with local clinical trial colleagues, clinical research organisations and clinical trial managers in order to respond timeously to Regulatory Authority queries.
- Co-ordination of meetings with the Regulatory Authorities to discuss clinical recommendations or any other clinical related matters, together, as required with the local and global clinical trial colleagues.
- Submission of two weekly and/or six weekly progress reports to Boards of Health and/or Ethics Committees for all ongoing clinical studies and end of study notifications as applicable.
- Ensure timely communication of any GCP breaches, or actions taken for safety reasons as required.
- Responsible for the co-ordination of regulatory activities associated with CTA submissions, including the development and submission of responses to HA queries and requests, and monitoring and following-up on progress of CTA submissions at the HA.
- Ensure compliance with local regulations, corporate regulatory processes, SOP’s and systems.
- Maintain compliance in company-specific regulatory systems, databases and local regulatory drive to ensure a state of audit readiness.
- Participate in internal audits as required.
- Represent regulatory affairs at CTA meetings as applicable.
- Where required, represent company at the relevant industry trade association meetings.

**Reporting Structure**:Regulatory Affairs Manager, Clinical trials

**Minimum Requirements**:
Bachelor of Science degree/Bachelor of Pharmacy degree

Demonstrable experience across the product development, commercialization and maintenance lifecycle

Proven ability to manage complex regulatory issues

Proven ability to consistently deliver to time, cost and quality standards

**Technical Skills**:

- In-depth knowledge of new and emerging Acts, Regulations and guidelines pertaining to the pharmaceutical industry.
- Knowledge of clinical trial methodologies ICH/GCP, FDA and local country regulations whilst useful is not critical.
- Knowledge of clinical trial and regulatory requirements as pertaining to human medicines.

**Behavioural skills and**
**Attributes**:Strategic thinker

Strong communication skills

Negotiation skills

Problem-solving abilities

Strong detail, quality and compliance orientation

Ability to understand stakeholder needs

Building strong peer relationships

Team player

Interpersonal acumen

‘Big-picture’ thinking

Analytical thinking

Change agility/adaptability

Ability to work under tight deadlines and with multiple conflicting priorities

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

LI-PFE



  • Sandton, South Africa BD Full time

    **Job Description Summary**: We have an exciting opportunity in Johannesburg for a Regulatory Affairs Specialist. This will be a hybrid based role and you will be responsible to develop, maintain and execute the Southern Africa regulatory operational plans. **We are the makers of possible**: BD is one of the largest global medical technology companies in...


  • Sandton, South Africa BD Philippines Full time

    **Be part of something bigger at BD.** Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning...


  • Sandton, South Africa Performer Recruitment Full time

    Job DescriptionWe are seeking a results-driven Corporate Affairs Director to join our team in South Africa. The ideal candidate will have a strong background in managing regulatory, public affairs, and communications. Key responsibilities include:Main ObjectivesEvaluate the operational landscape and anticipate changes.Devise strategies to mitigate risks and...


  • Sandton, South Africa Performer Recruitment Full time

    Corporate Affairs DirectorA well-established FMCG company is looking for a Corporate Affairs Director. The individual in this role is tasked with evaluating the operational landscape within South Africa. This involves forecasting changes in the environment that may pose commercial risks or present competitive opportunities for the company. They are also...


  • Sandton, South Africa Performer Recruitment Full time

    Job RequirementsWe are looking for a talented Corporate Affairs Director to join our team in South Africa. The ideal candidate will have a strong background in managing regulatory, public affairs, and communications. Key responsibilities include:Main ObjectivesEvaluate the operational landscape and anticipate changes.Develop effective strategies to shape the...


  • Sandton, South Africa Solventum Corporation Full time

    Quality and Regulatory Affairs Specialist - Medicines and Medical DevicesJoin to apply for the Quality and Regulatory Affairs Specialist - Medicines and Medical Devices role at Solventum.Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off...


  • Sandton, South Africa Pfizer Full time

    The Oncology Senior Medical Manager is responsible for developing and executing the medical plan that supports the strategic operating goals for the oncology business, supports cross-functional projects, and is accountable for his/her medical and scientific initiatives related to oncology products. To develop strategic partnerships with key external...


  • Sandton, South Africa Solventum Full time

    **3M**H**ealth**C**are is now**S**olventum** At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for...


  • Sandton, South Africa Mednurse Full time

    Are you passionate about patient safety and quality care? Join our client in Zambia as a Clinical Quality Assurance Coordinator. You'll lead initiatives to enhance patient outcomes, ensure compliance with quality standards, and drive continuous improvement in clinical care. Requirements : RN qualification (Bachelor's in Nursing essential) 6+ years of nursing...


  • Sandton, South Africa Discovery Limited Full time

    Discovery's core purpose is to make people healthier and to enhance and protect their lives. We seek out and invest in exceptional individuals who understand and support our core purpose, and whose own values align with those of Discovery. Our fast-paced and dynamic environment enables smart, self-driven people to be their best. As global thought leaders,...


  • Sandton, South Africa BD Full time

    **Job Description Summary**: The Medical Manager, MDS is an exciting opportunity in South Africa. They will be a key member of the BD MDS Africa Leadership Team and of the EMEA Medical Affairs leadership team who will engage with key HCP (healthcare professionals) across the region to have scientific & medical discussions, engage with key societies who...


  • Sandton, South Africa IIE Varsity College , IIE Vega and IIE MSA Full time

    **Direct Reporting Line**: Dean: Faculty of Law **Overall Purpose of the job**: **Duties and Responsibilities**: **Case Management and Legal Processes** - Interpreting laws, rules, and regulations - Manage all matters from time of consultation until such time as matter is litigated, closed or referred to an Attorney or Advocate within the required standards...

  • Junior Bookkeeper

    2 days ago


    Sandton, South Africa MPRTC Full time

    **Requirements** - Minimum 1 year bookkeeping experience, up to Trial Balance - Minimum 1 year experience in Pastel, up to Trial balance - Knowledge of bookkeeping practices - Knowledge of generally accepted accounting principles and procedures - Knowledge of relevant legislation and regulatory requirements


  • Sandton, South Africa DSM Full time

    Our client is searching for a Hub and Linehaul Manager to join their team in Benoni.Basic FunctionThe responsibility of the Hub and Linehaul Manager is to provide strategic planning, leadership, and coordination of the business unit functions across operational, HR/IR, and financial disciplines. This includes monitoring and analyzing operational efficiencies...

  • Medical Head

    2 weeks ago


    Sandton, South Africa Ariston Global Full time

    The Medical Head is responsible for developing and executing the medical strategy to ensure scientific excellence, regulatory compliance, and strong engagement with healthcare professionals (HCPs). This role will oversee medical affairs, policy development, risk management, and stakeholder collaboration, ensuring that all initiatives align with global best...


  • Sandton, South Africa Pfizer Full time

    Why Patients Need You Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary...


  • Sandton, South Africa Boardroom Appointments Full time

    Job Description:This role involves preparing and analyzing financial reports, as well as liaising with internal and external stakeholders. A strong understanding of financial regulations and compliance is essential.Main Responsibilities:Preparing and analyzing monthly financial reports, including profit and loss, balance sheet and capital statements....


  • Sandton, South Africa Boardroom Appointments Full time

    About the Job:We are seeking a highly skilled Financial Accountant to join our team. The successful candidate will be responsible for performing a variety of financial tasks, including financial reporting, budgeting and forecasting.Key Tasks:Preparing and analyzing monthly financial reports, including profit and loss, balance sheet and capital statements....


  • Sandton, South Africa Boardroom Appointments Full time

    Job Summary:As a Financial Accountant, you will be responsible for managing a variety of financial tasks, including financial reporting, budgeting and forecasting. You will also be required to liaise with internal and external stakeholders, including auditors and senior management.Main Responsibilities:Preparing and analyzing monthly financial reports,...


  • Sandton, South Africa Trate South Africa Full time

    ResponsibilitiesSales and Business Development: Identify and develop new business opportunities within the dental market, generate and qualify leads through various channels, present product demonstrations and presentations to potential customers, negotiate contracts and close deals, achieve and exceed sales targets.Customer Relationship Management: Build...