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Regulatory Affairs Operations Lead

2 weeks ago

Midrand, Gauteng, South Africa Adcock Ingram Full time R250 000 - R500 000 per year

REGULATORY AFFAIRS OPERATIONS LEAD AI OTC - MIDRAND

Adcock Ingram Holdings Limited and its Subsidiaries ("we", "us") is committed to protecting and respecting your privacy. Our Privacy Notice sets out the basis on which personal information collected inter alia from you, social media, recruitment agencies and our website, will be processed by us. The Privacy notice is available on our website .

One of the conditions under the Protection of Personal Information Act 4 of 2013 (POPIA) provides that candidates have the right to be informed about the collection and use of their personal information,

In the course of your application: we may

  • collect personal information that may be used to identify potential professional opportunities other than the job you have applied for but of which we think might be of interest to you.
  • use your Personal Information to confirm references or background checks you have provided us.
  • request your consent to participate in aptitude tests or recruitment

We also use your personal information to respond to your inquiries, to verify your information and to share information with you.

Your personal information will be securely stored by the Human Capital Department and it will be retained for a period of up to 12 months as of the closure of the application procedure if your application is unsuccessful, and in case of a successful application and you are hired, your data will be transferred to your personal employee file.

By applying for this position, you consent to us processing your personal information.

We reserve the right to make an appointment. If you have not heard from us within 30 (thirty) days of the closing date, please accept that your application was unsuccessful. Correspondence will be entered into only with shortlisted candidates.

Reporting to Head: Regulatory Affairs OTC

Job purpose:

The Regulatory Affairs Operations (RegOps) Lead is responsible for overseeing Regulatory Operations activities and strategic initiatives in support of pre- and post-approval filing as well as ongoing document maintenance efforts within the OTC division. The position requires participation in and supervision of formatting, publishing, compilation and submission of all regulatory documentation to national and international regulatory authorities. This individual will be a key member of multi-disciplinary project teams, maintain submission-planning timelines for assigned submissions, and implement submission strategies together with Regulatory Affairs Personnel. The RegOps Lead will oversee activities for assigned projects and will also be responsible for supporting the development of reports or activities to implement new technology solutions in support of the Regulator Affairs Systems division.

Qualifications/experience:

  • Pharmacy Bachelor's degree or equivalent in life sciences or technology-related discipline with minimum 2 years Regulatory Operations experience required.

OR

  • Grade 12 with at least 5 years pharmaceutical industry experience, with prior Regulatory Operations experience required.

  • Experience leading the management of projects/timelines and collaborating with team members

  • Expertise in the use of a document management, eCTD format and regulatory submission requirements and eCTD publishing systems

  • Advanced technical skills in best business practices for electronic regulatory document preparation and submission, and document and life cycle management systems

  • Previous experience developing work instructions and generating SOP's that are consistent with health authority requirements and company business practices

  • Proven ability to manage, streamline and collaborate to improve document preparation and management systems

Key Job Outputs

  • Responsible for overseeing and guiding the operations of teams managing the creation, assembly, and publishing of electronic submissions, including New Product Applications and Life Cycle Amendments.

  • Represents Regulatory Operations on project teams for matters relating to electronic submissions, driving timelines and deliverables related to submission documents.

  • Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities, ICH and internal working practices.

  • Liaise with functional source areas (clinical, quality, regulatory) to ensure documents are compliant with authoring style guide. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.

  • Supports and/or leads the development, refinement, and implementation of internal processes, procedures, work instructions and training programs for submission production and operational support activities to the RA Systems Department. As needed, trains colleagues and project teams.

  • Ensure alignment of personal and company values.

Closing date of applications: 15 October 2025

Core competencies

  • Advanced technical skills in best business practices for electronic regulatory document preparation and submission, and document and life cycle management systems

  • Excellent negotiation and relationship development skills to effectively interact with vendors and partners

  • Demonstrated advanced leadership, problem solving and organizational skills

  • Excellent oral and written communication skills

  • An ability to be productive and successful in an intense work environment

  • Knowledge of industry trends regarding electronic submissions.

  • Technical knowledge of electronic publishing systems and software.

  • Proficiency with MS-Office Suite and Adobe Acrobat application

  • Must demonstrate responsibility, excellence and collaboration and align with Company values.