Reporting Structure: Regulatory Affairs Manager, Clinical Trials
We have an exciting opportunity available for an experienced Regulatory Affairs Clinical Trials Pharmacist / Specialist who will support our client’s Regulatory Affairs Department.
- Bachelor of Science degree/Bachelor of Pharmacy degree
- Minimum of 3 years experience in Regulatory Affairs in the clinical start-up applications and amendments
- Demonstrable experience across the product development, commercialization and maintenance lifecycle
- Proven ability to manage complex regulatory issues
- Proven ability to consistently deliver to time, cost and quality standards
- In-depth knowledge of new and emerging Acts, Regulations and guidelines pertaining to the pharmaceutical industry.
- Knowledge of clinical trial methodologies ICH/GCP, FDA and local country regulations advantageous
- Knowledge of clinical trial and regulator requirements as pertaining to human medicines
- Strategic thinker
- Strong communication and skills Negotiation skills
- Problem-solving abilities
- Strong detail, quality and compliance orientation Ability to understand stakeholder needs
- Building strong peer relationships Team player
- Interpersonal acumen ‘Big-picture’ thinking
- Analytical thinking
- Change agility/adaptability
- Ability to work under tight deadlines and with multiple conflicting priorities
Responsibilities will include:
- Develop strong cross-functional partnerships with in-country and above-country colleagues to effectively execute submission strategies for new and existing clinical trial applications.
- Enhancing and managing relationships with regulatory health authorities (HAs) and Boards of Health (BoHs).
- Understand local regulations, guidelines and developing trends in the local regulatory environment.
- Leverage regulatory knowledge to anticipate barriers and recommend alternative approaches in line with local policies and procedures.
- Liaise with clinical research project managers and local clinical oversight colleagues to seek to understand clinical research programmes as required.
- Assist as applicable with any regulatory- related country feasibility questions and regulatory intelligence.
- In partnership with above-country operational hubs, above-country clinical trial managers, local clinical operations, third party vendors and clinical research organisations, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority queries as required.
- Participation in discussions with local clinical trial colleagues, clinical research organisations and clinical trial managers in order to respond timeously to Regulatory Authority queries.
- Co-ordination of meetings with the Regulatory Authorities to discuss clinical recommendations or any other clinical related matters, together, as required with the local and global clinical trial colleagues.
- Submission of two weekly and/or six weekly progress reports to Boards of Health and/or Ethics Committees for all ongoing clinical studies and end of study notifications as applicable.
- Submission of new clinical trial applications and amendments to the required Ethics committees for approval as applicable.
- Ensure timely communication of any GCP breaches, or actions taken for safety reasons as required.
- Responsible for the co-ordination of regulatory activities associated with CTA submissions, including the development and submission of responses to HA queries and requests, and monitoring and following-up on progress of CTA submissions at the HA.
- Ensure compliance with local regulations, corporate regulatory processes, SOP’s and systems.
- Maintain compliance in company-specific regulatory systems, databases and local regulatory drive to ensure a state of audit readiness.
- Participate in internal audits as required.
- Represent regulatory affairs at CTA meetings as applicable.
- Where required, represent company at the relevant industry trade association meetings