Start-up Regulatory Specialist

2 weeks ago

Johannesburg, Gauteng, South Africa Novo Nordisk Full time

The Position

Your main accountabilities will be:


As a Start-up Regulatory Specialist you will be responsible for taking leadership of site start up activities of the appointed studies in compliance with all local regulations, ICH - GCP, Novo Nordisk Procedures and protocol requirements.


  • Manage and execute the startup activities in the allocated clinical trials in compliance with SAPHRA, local regulations, ICH-GCP, Novo Nordisk procedures and protocol requirements.
  • Familiarise themselves with all applicable local submission guidelines from health authority, IRB's, IEC's etc
  • Preparation and submission of local Clinical Trial Application to Health Authorities and IRB/IEC as soon as possible to obtain all necessary regulatory approvals within defined timelines.
  • Informing Global RA-CTAmgmt of the local CTA documents requirement for specific trial projects needed for initial submissions.
  • Liase with CTA's and /or Clinical trial sites with respects to obtaining submission documents from selected sites.
  • Ensure that the documents are timely collected and in compliance with NNSOP and regulatory requirements.
  • Customisation of Master (patient) Documents and obtaining approvals from Global team.
  • Coordination of translation with approved local/global vendors (where applicable
  • Responsible for corresponding the queries to the International Clinical Trial team (where applicable).
  • Obtaining Export Licence from Department of Health (DOH) and submitting the biannually DOH reports during the conduct of the trial.
  • Obtaining Materials Transfer Agreement (MTA) approval from both International Clinical Trial Colleagues, the laboratory and IRB's/IEC's
  • Setup initial Greenlight
  • Primary responsible person for communication with HA and ECs during the trial lifecycle

Qualifications

  • Min. 3 years of experience in pharma industry, preferably in startup activities, previous CRA experience must have.
  • Min. bachelor's degree in health science.
  • Ability to build and maintain strong working relationships with internal and external stakeholders. Strong communication skills, attention to detail, very good organizational skills.
  • Team oriented personality with high degree of flexibility close collaboration with the sites, stakeholder, vendors, and regulatory team.
  • High focus on delivery and quality.
  • Fluent English.
  • Knowledge of local legislations related to clinical trials.
  • High result orienting in driving of startup milestones according to CDC Start Up KPIs.
  • Ability and willingness to adjust quickly to new situations in a continuously developing environment.
  • Proven decision making and problemsolving capabilities.

About The Department
Working with the clinical trial team in South Africa and collaborating across SEEMEA and International Operations.

You will join an expanding dedicated clinical team of Clinical professionals on a mission to create better treatments and care for patients with Diabetes, Obesity, Rare Disease and the new therapeutic areas (Cardiovascular Diseases, Alzheimer's Disease, NASH, Sickle Cell Disease) that Novo Nordisk is investing in.


Working at Novo Nordisk
Novo Nordisk is its people.

We know that life is anything but linear and balancing what is important at different stages of our career is never easy.

That's why we make room for diverse life situations, always putting people first.

We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them.

Working at Novo Nordisk is working toward something bigger than ourselves, and it's a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we're life changing.

Contact

Deadline
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.


At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world.

We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures.

We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.

Together, we're life changing.

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