Senior Regulatory Manager at AstraZeneca

What you’ll do?

As the successful candidate, you will have an opportunity to work with a passionate team of individuals dedicated to accelerating access to life-changing & innovative medicines for our patients. In addition, gain exposure and network to Health Authority regulatory framework across the various SSA countries within the African Cluster. Prepare regulatory tactical submission plans for allocated project/products that implements the agreed regulatory strategy to develop and maintain products. Provides independent tactical/scientifically related guidance cross functional on aspects of regulatory affairs. Uses knowledge and experience in the regulatory field to influence functional objectives.

You will act as Qualified Person Responsible for Pharmacovigilance (QPPV) and ensure compliance with both AstraZeneca requirements and global and local regulatory requirements for patient safety. You will also be responsible for managing skill development and performance management of your direct reports and resource allocation.

Typical accountabilities will include:

REGISTRATION PLANNING AND BUSINESS SUPPORT

Implement registration plans and provide support to Commercial.

• Implement the registration business plan for regulatory affairs that reflects the business objectives of the SSA MC and aligns with brand marketing strategies to deliver business critical regulatory needs within agreed timelines.
• Provide regular feedback to Head of Regulatory Affairs, marketing, and sales teams on the regulatory submission progress of specific products and ensure that all teams have up to date regulatory information and support needed to drive performance in their respective departments.
• Proactively identify issues and manage risk taking appropriate action as required on regulatory submission in collaboration with Regulatory Affairs manager and identify and drive ongoing improvements.

GOOD REGULATORY PRACTICE (GRP)

• To implement GRP standards in the SSA Hub in line with International Procedure 1-P56-cv-X "Good Regulatory Practice in AstraZeneca" that support license to operate across the Regulatory Value Chain.
• Implement GRP standards in the following process areas:
  • Marketing Authorization Applications.
  • License maintenance.
  • Pharmacovigilance.
  • Submission’s compilation and dispatch.
  • Management of Regulatory Knowledge (including Regulatory Product Knowledge and Regulatory Status Information).
  • Health Authority interactions.

Ensure an "inspection-ready" Quality System, providing evidence that there are mechanisms in place to ensure that license to operate regulatory activities are being met in accordance with legislation and AZ GRP procedures.

•  To track and manage all GRP activities and report any non-compliances to the GRP lead.
•  To ensure that all local SOPs and checklists are updated in line with global SOPs.
•  To monitor GRP progress and initiate improvement plans for the SSA Hub QMS.
•  Complete training in line with the Saba Cloud training matrix relevant to job profile.

REGULATORY PROCESS FOR ALLOCATED PRODUCTS/MARKETS

• Ensure that the regulatory processes for allocated markets/products are performed timeously in line with GRP.

Marketing Authorization Applications:

Submit Marketing Authorization

• Applications to Health Authorities according to SSA HA guidelines and GRP, in the shortest possible time based on business priorities.

License maintenance:

• Ensure all post approval product maintenance activities including CMC variations, package insert safety updates, new indications, technical changes to the label or the packs, PBRERs, and post approval commitments are submitted and approved.
• Ensure all License Renewals are submitted on time, prior to license expiry or in accordance with the planned submission date.

Pharmacovigilance:

• Ensure individual PBRERs (where required) are submitted to Health Authorities timeously.

Submissions compilation and dispatch:

• Assess registration documents for adequacy of information.
• Obtain relevant information from Global.
• RA and resolve queries as they arise to ensure delivery of submissions within agreed timelines.

 Health Authority interactions:

• All communication with Health.
• Authorities regarding submissions, product registration or maintenance throughout the lifecycle of the product is managed effectively via the SSA in-market contact/distributors.

ESTABLISHED STAKEHOLDER RELATIONSHIPS AND CONSOLIDATED REGULATORY ROLE

• Develop and maintain relationships with key internal and external customers and maintain visibility and accessibility, working in close collaboration with them to realize AZ objectives.

Build and maintain relationships with Health Authorities to influence regulatory timelines and outcomes

• Communicate regularly with SSA MC colleagues regarding regulatory requirements and objectives and share best practice ideas.
• Represent AZ to key players and other identified stakeholders.
• Attend local trade association meetings to network with other Pharmaceutical Companies for updates to regulatory requirements and best practices across SSA.

ESSENTIAL SKILLS & EXPERIENCE REQUIRED?

Essential

• Bachelor’s Degree in Pharmacy. Advanced degree a plus.
• Valid and available Annual Practice License for the Pharmacist.
• Registered with Pharmacy and Poisons Board.
• Significant experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or in regulatory drug development, product approval/launch, line extension and license maintenance, or experience at a health authority.
• Project and process management.

Desirable

• Drives Performance – holds others accountable to high standards and clarifies what needs to be done and the consequences for the individual and/or the organization.
• Works collaboratively – respects and integrates diverse views into decisions/proposals.
• Problem solving