Program Manager - Regulatory Affairs - Pharma

Hiring Program Manager Regulatory Affairs

The program manager is responsible to lead and have the overall accountability to deliver the outcomes and benefits to the strategic objective to the assigned program

Main tasks

- Overall responsibility and accountability of the assigned program.

- Responsible for defining and oversight of dependent workstreams (interconnected projects) needed to reach the overall strategic goals of the program.

- Responsible for acting as a Program manager for one of the projects with Global Exposure.

- Core experience from CMC background managing Regulatory Affairs.

- Global Experience working for a European or US Market is mandatory

- Responsible for acting as a Program manager for one of the projects with Global Exposure.

- Global Experience working for a European or US Market is mandatory

- Core responsibilities include Managing P&L, client interaction, delivery management, and team management.

Reporting to Associate Director Regulatory Function from India & Germany.

Regulatory Function from India & Germany.

- Responsible and accountable for overall budget management including planning, forecasting, and monitoring of the assigned program.

- Daily program management throughout the program life cycle

- Responsible to produce accurate and timely reporting of program status to internal and external stakeholders

- Primary contact for the client about the program status (activities and performance management), issue escalation, and general topics related to the program.

- Ensures effective client and/or internal stakeholder management in close collaboration with KAM if assigned.

- Defines and communicates agreed on RACI and program governance

- Ensures program staffing/re-staffing and backup staff to manage program continuity

- Set up Operational Program Team with clearly defined roles, assign responsibilities, accountabilities, and work packages

- Managing and leading a program team with a diverse array of talents and responsibilities

- Defines and implements internal and external communication plans. Ensures adequate and transparent internal program team, cross-VDC and cross-country communication

- Creates and maintain the program documentation, including all plans, timelines and reports

- Defines and reports KPIs

- Ensures budget from work order is monitored and invoiced and informs client on potential risks to the budget or change orders needed

- Identifies and manage risks and takes mitigation measures. Develops a robust risk mitigation plan

- Integrates cross-VDC experts, Consultants and Alliance partners into the program, if needed

- Ensures relevant PM standards, workflows and process are implemented

- Leads internal and external events and workshops

- Identify opportunities for continuous improvement

- Key driver to ensure renewal of programs, i.e. steer RFP and bid defense process; responsible to have appropriate delegation for all roles in such a process defined

Key performance indicators

The following KPIs will be arranged individually with the Service Area specific measures (if available) between the supervisor and job holder:

- Establishment of and adherence to common standards in program management

- Client Satisfaction

- Program Team Satisfaction

Key Decisions made by Senior Manager

Day-to-day decisions regarding allocated programs, tasks, including budgetary management, program management topics and client interactions.

Critical qualifications, experience, 'know-how' and skills - preferred set

- Successful completion of a Masters's Degree or equivalent in pharmacy or other natural sciences

- procedures, renewals, variation procedures).

Exposure of working in a clinical research organization preffered.

- Autonomous, concentrated and high-quality work

- Ability to deliver and effectively manage strategic goals for the business as well as strategic goals of partnerships with clients; ability to balance client requests, employee and company interests

- Excellent understanding of the business economical areas; proven experience and delivery in other business areas including BD

- Structured, analytical, systematic and independent way of working

- Ability to adjust rapidly to new, unknown, challenging situations; delivery of strategic outputs and take action consistent with operating policies

- Lead change management activities and provide consultation

- Proactively identify and manage up/cross selling opportunities;

- Ability to analyse problems and propose solutions at a business level

- Ability to lead large and/or complex program teams, distribute work equally and according to team member's strengths, developing and motivating both junior and experienced colleagues; convincing others in difficult change management situations

- Ability to manage/lead internal and external client relationships on client's department head level; ability to convey strategic goals of collaboration and be an ambassador for the company.

- Excellent communication skills (written and verbally)

- Proven capability to communicate critical issues, analyze and propose appropriate solutions to decision makers and business heads.

- Excellent presentation skills