Job Description

Job Summary Summary
The RAM acquires and maintains all the required licenses to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
Supporting one or more products from a regional regulatory perspective.

Strategy and Execution

• Plan and manage regulatory submissions (e.g., clinical trial and marketing applications) for products BIOCAD / ANABION portfolio in compliance with global filing plans and local regulatory requirements.
• Under general supervision, implement product-related regulatory strategies, Regulatory Affairs processes, and activity planning in accordance with national legislation and regulatory requirements.
• Provide content guidance for regional regulatory documents and meetings in accordance with a global company.
• Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g., expediting FIH studies, Orphan Drug, Fast Track, compassionate use).
• Support regional label negotiation activities.
• Under general supervision participate in the development, and execution of regional regulatory product strategies.
• Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.
• Maintain an awareness of new and developing legislation, regulatory policy, and technical Regulatory guidance relating to BIOCAD / ANABION.
• Perform regulatory research to obtain relevant histories, precedence, and other information relevant to regional product advancement.
• Under supervision evaluate and communicate the impact of relevant regional regulations, guidance, current regulatory environment, and competitor labelling.
• You will be joining the Multinational Medicine Regulatory team. You will be working with colleagues, who are responsible for leading the International regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the product lifecycle.
• This team leads the regulatory activities for established products and development assets in the Oncology, AID & Orphan disease areas, as well as pre-approval filing for Biosimilars & Generics.

Required qualifications and skills

• Scientific Degree and demonstrated experience in a similar role.
• Regulatory principles:

• Working with policies, procedures, and SOPxe2x80x99s.
• Knowledge of legislation and regulations relating to medicinal products.
• Awareness of the registration procedures in the region for clinical trials, MA, post-approval changes, extensions, and renewals.
• Knowledge of drug development.
• Knowledge of and experience in the regional regulatory environment.
• Strong communication skills - both oral and written.
• Ability to understand and communicate scientific/clinical information.
• Ability to anticipate and prevent potential issues.
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

Location
Flexibility to work from home, with a few days per week working from our regional (Cape Town) office.

Greys Recruitment

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