Regulatory Affairs Specialist

2 weeks ago

Johannesburg, South Africa Icon plc Full time

ICON Biotech Solutions Global Regulatory Clinical Services (GRCS) team helps ICON’s clients navigate the intricate regulatory agency and ethics committee approval and life cycle challenges.

As a Regulatory Affairs Specialist at ICON Biotech Solutions you would fulfil the Local Regulatory Affairs Associate (LRAL) role. The LRALs provide “on-the-ground” support for gaining clinical trial authorisation from all country-level authorizing bodies including the Regulatory Agency and Central Ethics Committee (CECs). The LRALs prepare submissions according to requirements in the local language and facilitate the assessment-including rapid responses-to questions based on their understanding of current country expectations and rate-limiting factor.

Local regulatory affairs associates (LRALs) are the powerhouses accountable for all the country-level approvals. The LRAL would be responsible for preparing submissions, working through the assessment process to the successful approval from ANSM.

GRCS have a thriving team culture which is at the heart of its success and the leadership team are committed to developing continuous learning opportunities for all where we challenge you with engaging work and where your experience adds to your professional development.

The Role- Providing advice and support to the project team for regulatory operations aspects of the projects.- Managing and ensuring maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.)- Maintaining strong customer service management approach with clients.- Leading project teams and advising departments on regulatory standards issues and strategies- Developing, writing, and implementing standards and procedures related to regulatory operations.- Identifying client issues and developing alternative strategies for presentation to client consulting with other resources within organization as required- Participating actively in other business related projects (business opportunities, client specific issues, etc.) and planning.- Client consultation and preparation of quotes and is responsible for achieving utilization goals of the EU unit.- Completing other appropriate duties as assigned by line manager that require similar skills

You are:
To be successful in this role you need to be an effective communicator, have strong organizational skills, a willingness to learn and be able to approach problems with a creative and collaborative mindset.- Experience in eCTD, NeeS, Paper Submissions.- Experience in EU, US and Canada HA submissions.- Experience in Lorenz Docubridge and ISI Tool Box- Experience in sequence building and document level publishing- Good knowledge on the CTD sections.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

Are you a current ICON Employee? Please click here to apply:
link

  • Regulatory Affairs Specialist

    6 days ago

    Johannesburg, Gauteng, South Africa TransUnion Full time

    Job DescriptionAs a Regulatory Affairs Specialist at TransUnion, you will provide group-wide accurate, expert, specialist, relevant, quality regulatory compliance advice, compliance review and assessment services for all TU Africa regions.Assist Management in executing applicable regulatory requirements by identifying them and making them aware of their...

  • Regulatory Affairs Director

    6 days ago

    Johannesburg, Gauteng, South Africa MVG Recruitment Specialists Full time

    Job OverviewMVG Recruitment Specialists is seeking a highly skilled Regulatory Affairs Manager to lead our Regulatory team and ensure legal compliance with relevant medicine regulatory authorities.This is an excellent opportunity for a seasoned professional to drive regulatory strategy, manage work streams, and report on assigned portfolios.

  • Regulatory Affairs Specialist

    1 week ago

    Johannesburg, South Africa iProcess Global Research Inc Full time

    JOB SUMMARY ESSENTIAL DUTIES Using a broad base of knowledge and understanding of regulatory requirements, assumes major responsibility for one or more major regulatory affairs areas Identifies and defines contents for Regulatory filings/dossiers. Leads the assembly and creation of these documents for their timely submission to Regulatory...

  • Regulatory Affairs Specialist

    1 day ago

    Johannesburg, Gauteng, South Africa Emporium Full time

    **Job Summary:**We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium.The successful candidate will be responsible for managing work streams and reporting on assigned portfolios of products, including internal and external product queries.Key Responsibilities:Establish regulatory priorities and allocate resources and...

  • Regulatory Affairs Pharmacist

    5 days ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 71064 **Job Type** - Permanent **Job Title** - Regulatory Affairs Pharmacist **Computer Skills** - Adobe Acrobat,MS Excel **Industry** - Manufacture **City** - Johannesburg **Province** - Gauteng - Reporting to RA Systems Manager**Job purpose** - Maintain applicable regulatory affairs information management electronic systems, ensuring...

  • Regulatory Affairs Pharmacist

    3 weeks ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72665 **Job Type** - Permanent **Job Title** - Regulatory Affairs Pharmacist **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng - Reporting To Regulatory Affairs Manager / Senior RA Pharmacist**Job Purpose** - To Support the Regulatory Affairs team with...

  • Regulatory Affairs Manager

    1 hour ago

    Johannesburg, Gauteng, South Africa Dymaxa Recruitment Full time

    Job Opportunity: Regulatory Affairs ManagerDymaxa Recruitment is seeking a qualified Regulatory Affairs Manager to oversee compliance and regulatory activities for our client's organization.About the Job:This is an excellent opportunity for a seasoned professional to lead the development and implementation of regulatory strategies and procedures.Key...

  • Regulatory Affairs Pharmacist

    1 week ago

    Johannesburg, South Africa MedicalCareers Full time

    A Pharmaceutical company has an opportunity for an experienced Regulatory Affairs pharmacist to join their team. Subordinates/ Direct Reports: Zero Main Purpose of Job To fulfil the position as regulatory affairs pharmacist for the company and any division within the group. Key Performance Areas (Core, essential responsibilities -outputs of the...

  • Regulatory Affairs Manager

    5 days ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72786 **Job Type** - Permanent **Job Title** - Regulatory Affairs Manager **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng **Reporting to Head: Regulatory Affairs** **Job purpose**: - Support the Regulatory team to provide superior Regulatory services...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, Gauteng, South Africa Emporium Full time

    Join to apply for the Regulatory Affairs Pharmacist role at Emporium in Johannesburg, Gauteng, South Africa.PURPOSE OF THE JOB:Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio outputs. To ensure legal compliance with...

  • Regulatory Affairs Systems Associate

    1 week ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 68543 **Job Type** - Permanent **Job Title** - Regulatory Affairs Systems Associate **Computer Skills** - MS Excel,Adobe Acrobat **Industry** - Manufacture **City** - Johannesburg **Province** - Gauteng - Reporting to RA Systems Manager**Job purpose** - Maintain applicable regulatory affairs information management electronic systems,...

  • Regulatory Affairs Pharmacist

    1 week ago

    Johannesburg South, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (POS24192)Area; AerotonSalary R750 800kPurpose of the role:Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio outputs. To ensure legal compliance with the relevant medicine Regulatory...

  • Senior Regulatory Affairs Pharmacist

    6 days ago

    Johannesburg, South Africa PSM Personnel Full time

    Senior Regulatory Affairs Pharmacist Pharmacist ~ Regulatory Johannesburg North-Gauteng Qualifications/experience - Bachelors Degree or Diploma in Pharmacy with the South African Pharmacy Council registration. - +-5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end...

  • Junior Regulatory Affairs Pharmacist

    1 week ago

    Johannesburg, South Africa Unique Personnel Full time

    **Job Number** - 72214 **Job Type** - Permanent **Job Title** - Junior Regulatory Affairs Pharmacist **Computer Skills** - Ms Office **Industry** - Manufacture **City** - Johannesburg (Incl. Northern Suburbs) **Province** - Gauteng - Reporting To Regulatory Affairs Manager / Senior RA Pharmacist**Job Purpose** - Entry Level position to Support the...

  • Regulatory Affairs Pharmacist

    3 weeks ago

    Johannesburg South, South Africa Emporium Human Capital Full time

    Regulatory Affairs Pharmacist (POS24192)Area; AerotonSalary R750 800kPurpose of the role:Support the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio outputs. To ensure legal compliance with the relevant medicine Regulatory...

  • Director, Legal

    1 week ago

    Johannesburg, South Africa Onafriq Full time

    We are recruiting for a Director, Legal & Regulatory Affairs to join the Governance, Risk and Compliance team at Onafriq. This role will be responsible for managing the legal and regulatory affairs function and through their team will provide (a) legal advice and guidance across the Group, and (b) manage the Group’s regulatory agenda and engagements with...

  • Regulatory Affairs Pharmacist

    4 weeks ago

    Johannesburg, Gauteng, South Africa Emporium Full time

    Join to apply for the Regulatory Affairs Pharmacist - CC role at EmporiumRegulatory Affairs Pharmacist (CC) - POS24329Area: AerotonSalary: R900 - R1mQualifications:Bachelor's Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council+-5 years' experience in Regulatory Affairs, preferably in human medicines, including...

  • Regulatory Affairs

    7 days ago

    Johannesburg, South Africa Mass Staffing Projects Full time

    **Job Information** - Location- Manufacturing Jobs in Johannesburg- Salary- R940k - R720k- Job Type- Permanent- Education- B.Pharm- Experience- 3+ Years- Reference- RAPHARM9- - pharmacy.jobs(at)staffingprojects.co.za- Fax- 0866023398MSP Recruitment is currently recruiting for a Multinational Pharmaceutical organisation based in Johannesburg, who seeks to...

  • Regulatory Affairs Professional

    6 days ago

    Johannesburg, Gauteng, South Africa Human Accent Full time

    As a Medical Affairs Manager at Human Accent, you will play a vital role in supporting our team in the pharmaceutical industry. Your responsibilities will include providing critical medical input to enhance marketing and regulatory strategies.Primary ResponsibilitiesDeveloping new business partnerships with international companies.Collaborating with internal...

  • Regulatory Affairs Pharmacist/scientist

    6 days ago

    Johannesburg, South Africa Cipla Full time

    **Division**: **Regulatory Affairs** **Department**: **Integrated Product Development** **Employment Type**: Permanent **Job Purpose**: Support the Regulatory Affairs function in its pre-registration and/or post-registration dossier submission activities by assisting in data gathering, screening, collating and compiling of the dossiers, post-registration...