Regulatory Affairs Project Leader: Pride In Personnel

Key Job Responsibilities:

Monitor, track and support various launch activities (formulary status and post submission – pre launch changes).

Oversee planning & compilation of documentation by team members for submission to regulatory authorities. Ensure that submissions are filed according to agreed timelines and priorities.

Manage the provincial formulary workload and other affiliate activities.

Manage project timelines and provide timely status updates/ reports to management

Keep current of the changing regulatory environment and ensure team is trained. As well as co-ordinate and ensure all training tools are update for example: checklists and databases.

Review regulatory submissions in accordance with the relevant regulatory guidelines and manage the deficiency risk/ response process.

Provide guidance to team members in responding to regulatory authorities in relation to deficiency letters.

Provide guidance on and review annual reports to support changes and/or to manage the regulatory product life cycle as applicable.

Interact with internal and external customers as required to ensure that their requirements are understood and fulfilled in a timely and professional manner.

Monitor the status of the submissions with the provinces up to the time of listing of the product.

Communicate and liaison with the respective provincial agencies.

Update provinces, as deemed necessary, on changes to currently listed product.

Communicate submission status (listing of a product) to Marketing Department and other stakeholders, as requested in a timely manner.

Participate in meetings as required and provides feedback to team

Provide leadership and training to team members to ensure the balanced growth of individuals and the development of the team as a whole.

Provide timely and appropriate reports to the Associate Directory, Regulatory Affairs.

Perform other duties as assigned by the Associate Directory, Regulatory Affairs.

Relationship with Internal/External Customers & Stakeholders

Interact with other applicable departments with Company on Launch Activities.

Contributes towards the creation and promotion of an environment of teamwork and empowerment by sharing information with team members and management in a timely fashion.

Problem Solving Analysis

Resolve complex issues relating to submissions.

Acts as a specialized resource to management and other team members in developing potential courses of action to resolve more complex regulatory issues

Decision Making/Autonomy

Make complex interpretation and application of decisions relating to provincial regulatory guidelines, policies, and strategies.

Recommends and implement amendments to department/division policies, procedures and standards.

Leadership/Professional Development of Self & Others

Addresses complex regulatory activities in support of submissions.

Seeks guidance from other team members and Project Leader to enhance regulatory knowledge.

Creates a positive and creative team environment built on mutual trust and respect.

Deals effectively and fairly with all direct reports and ensures that all performance related issues are dealt with firmly and in a timely manner

Participates in the development and communicates department and division objectives.

Coaches direct reports and provides them accurate information empowering them with appropriate knowledge required to carry out their tasks as assigned.

Champions & demonstrates corporate values and a commitment to the Company R & D goals.

Communicates corporate vision and goals to direct reports in an effective and efficient manner using both verbal and written communication as appropriate.

Attends R&D management meetings and communicates relevant information back to staff

Supports the Communication Lead and participates in Departmental presentations as required

Formulates, manages and follows-up on action plans taken for the ongoing development of self and team members.

Compliance & Due Diligence

Ensure compliance with SOPs and Regulatory Guidelines and Requirements.

Recommends and implements amendments to internal policies, procedures and standards for managing regulatory issues.

Maintains and further develops an in-depth understanding of all pertinent SOPs, plus GXPs, GLP, GCP, GMP, GDPs and Safe Work Practices pertaining to regulatory affairs.

Drive for Results

Assigns tasks and follows-up with direct reports on a regular basis to ensure that the regulatory process from compilation through to submission is completed as scheduled.

Job Requirements:

Minimum BSc degree or equivalent in Chemistry or Pharmacy or Life Sciences.

Minimum five years experience in the pharmaceutical industry with at least three years experience in senior Regulatory Affairs role.

Detailed knowledge of multiple regulatory requirements e.g., TPD, EU, TGA, etc.

Excellent oral/written communication, leadership, organizational and interpersonal skills.

Computer literate. Familiarity with IT systems, e.g. databases and various software packages.

Experience in leading a team of professionals would be an asset.