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27 May 2022

Regulatory Affairs Pharmacist at AstraZeneca

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Job Description


AstraZeneca is a global, innovation-driven Biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

ABOUT OUR REGULATORY TEAM

The team is strong and diverse, with members based in different markets in Africa. Our objective is to ensure regulatory organizational effectiveness and capabilities. Team members work collaboratively and cross functionally with colleagues in various departments, externally with the health authorities and distributors that serve as Local technical representatives. The team lives the values of “We play to Win” and “Put Patience First” enhancing the high-performance culture and accelerating submissions and approvals all-round the African cluster.

What you’ll do?

As part of high performing team, you will be applying your skills and knowledge to prepare and deliver regulatory submissions. Ensure compliance with the requirements from regulatory agencies.

As successful candidate, you will manage and control all registration processes defined by allocated countries, prepare and submit marketing authorization applications to Health Authorities according to local guidelines and GRP. Ensure all post-approval product maintenance activities are submitted and approved timely in addition to maintaining an elevated level of Regulatory Intelligence for the markets allocated.

Some areas of focus for this role will include:

  • Supports the Global Regulatory Leader in leading the delivery of timely submissions of business priorities in compliance with relevant AstraZeneca procedures and local market regulations.
  • Contributes to the strategy, direction, and efficient operation of the global submissions skill group by continuously enhancing the submissions organization and operating model.
  • Ensures eRegulatory business needs are incorporated within AstraZeneca Regulatory systems by being involved in developing requirements, processes, and standards, validating, and implementing them and supporting new systems and system enhancements.
  • Identifies budget priorities taking, careful note of portfolio growth and business needs
  • Serves the Global group in business projects as delegated by the Global Head Submission
  • Delivers project assignments supporting the business, e.g., representation or leadership on global cross-functional task forces
  • Obtaining essential marketing authorizations for AstraZeneca products and maintaining existing product licenses.
  • Management and assurance of regulatory compliance of the regulatory functions.
  • Ensure best practice in line with Good Regulatory Practice, current legislation, and standards of ethical and professional performance.
  • Implement registration plan and business support for allocated products
  • Implement GRP standards in the SSA markets in line with International Procedure 1-P56-cv-X “Good Regulatory Practice in AstraZeneca” that support License to Operate across the Regulatory Value Chain.
  • Ensure that the regulatory processes for allocated markets/products are performed timeously in line with GRP.
  • Submit Marketing Authorisation Applications to Health Authorities according to local guidelines and GRP, in the shortest possible time based on business priorities
  • Pro-actively Manage Regulatory Processes of Key Products (New products, Line Extensions and actively promoted products) and follow up with HA to ensure timely approvals
  • 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 at stipulated in the Global database.
  • Complete due diligence of registration documents/dossiers
  • Obtain relevant information from key global RA and resolve queries to ensure delivery of submissions within agreed timelines.
  • Timeous submission of all documents provided by AZ to the HA and immediate feedback to AZ after submission
  • Timeous provision of copies to AZ of all correspondence collected from the HA
  • Building sustainable relationships with the HA to achieve regulatory goals and regular follow up on all outstanding issues
  • Maintain an elevated level of Regulatory Intelligence e.g., on existing and developing regulations and on the overall competitive landscape in East Arica and SADC markets
  • Proactively collects necessary information from the project team, and plans all submission management related activities
  • Identifies resource needs for assigned submissions, and liaise with management to secure the required resources
  • Liaises with marketing companies and regional regulatory affairs staff regarding technical and format requirements on submission deliverables
  • Performs complex searches on submission life-cycle information, as required
  • Ensure labelling and artworks are effectively managed through the AstraZeneca Global Labelling Business Process using the GAZELLE system.
  • Shares experiences and contributes to establishing best practices
  • Manage pharmacovigilance activities in Ethiopia (QPPV)

If this sounds appealing, please read on to understand the experience and skills we’re looking for…

ESSENTIAL SKILLS & EXPERIENCE REQUIRED?

  • Registered Pharmacist (Pharm/PharmD) and 1st Degree in Basic science.
  • 2-4 years’ experience in a similar role.
  • Considerable experience of drug development in the Pharmaceutical industry.
  • Expertise in Information and document management technology and electronic/paper publishing software.
  • Excellent written and verbal communication skills.
  • Thorough knowledge of world-wide Health Authority requirements on Regulatory technical format including processes and technologies.
  • Resource Management skills.
  • Influencing and negotiating skills.




Method of Application

Submit your CV and Application on Company Website : Click Here

Closing Date : 15 June. 2022





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