Title:  Trainee

JOB PURPOSE:

To coordinate regulatory activities throughout the regulatory life cycle by carrying out project specific tasks related to writing and collecting submission documents from cross functional departments to ensure an efficient preparation of submissions that comply with latest regulations and within the defined timelines.

KEY ACCOUNTABILITIES:

Policies, Processes & Procedures:

§ Follows all relevant departmental policies, processes, standard operating procedures and instructions so that work is carried out in a controlled and consistent manner

Day- to-day operations:

§ Follows the day-to-day operations related to own job to ensure continuity of work

Job Specific Accountabilities:

§ Writes submission documentation including relevant correspondences with health authorities to fulfil submission requirements in an efficient manner that complies with standards and regulations.

§ Coordinates all regulatory activities for submissions throughout the regulatory life cycle from preparation, submission, deficiency letters to approvals and variations to ensure efficiency in execution for each step.

§ Maintains awareness of applicable regulations and guidance to keep up to date with the relevant guidelines and information that could impact on the regulatory projects.

§ Coordinates and follows-up with cross functional departments to ensure that submission documents are available in time to meet submission timelines and to ensure that documents meet the authority’s guidelines and standards.

§ Assists in data collection to contribute to the preparation of regulatory affairs department reports.

§ Communicate with third parties and licensors to ensure that submission documents are available in time to meet submission timelines and to ensure that documents meet the authority guidelines 2 Confidential and standards.
Continuous Improvement:

§ Contributes to the identification of opportunities for continuous improvement of processes and practices considering ‘international best practice’, improvement of business processes, cost reduction and productivity improvement

Reporting:

§ Assists in the preparation of timely and accurate reports of regulatory affairs to meet company and department requirements, policies and standards

Safety, Quality & Environment:

§ Complies with all relevant safety, quality and environmental management policies, procedures and controls to ensure a healthy and safe work environment.

Related Assignments:

§ Performs other related duties or assignments as directed.

Minimum Qualifications:

Bachelor’s degree Pharmacy or PharmD. Minimum Experience: 0 to 1 years’ experience in pharmaceutical industry.