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.

Description:

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

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

Writes submission documentations 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 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 guidelines and standards.  Assists in data collection to contribute in the preparation of regulatory affairs department reports.  Communicates 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 and standards.

Contributes to the identification of opportunities for continuous improvement of processes and practices taking into account ‘international best practice’, improvement of business processes, cost reduction and productivity improvement.

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

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

Performs other related duties or assignments as directed.

Minimum Qualifications: Bachelor’s degree Pharmacy or PharmD.

Minimum Experience: 0 to 3 years’ experience in biopharmaceutical industry.