Senior Director- Regulatory Affairs, Development & QMC

PharmaLex; United Kingdom; Remote; GBP 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Senior Director in Regulatory Affairs to lead strategic initiatives and enhance global services. This pivotal role involves collaborating with international teams to define and implement strategies that promote growth and service excellence. The successful candidate will leverage their extensive knowledge of regulatory frameworks and proven leadership skills to drive business development and foster strong relationships with stakeholders. If you are a dynamic leader with a passion for innovation in the pharmaceutical sector, this opportunity offers a chance to make a significant impact in a remote setting while working with a dedicated team of professionals.

Qualifications

• Degree in Life Science required with excellent knowledge of international legislation.
• Proven experience in international practice/service is essential.

Responsibilities

• Lead strategic planning and execution of VDC services.
• Develop and maintain global pricing structure for practice/services.

Skills

Interpersonal Skills

Strategic Thinking

Analytical Thinking

Communication Skills

Problem-Solving

Flexibility and Adaptability

Education

Degree in Life Science

Job description

Senior Director- Regulatory Affairs, Development & QMC

PharmaLex is a Cencora company.

We are seeking a Senior Director Regulatory Affairs /Development/QMC to represent the respective Practice/Services internally to PharmaLex and externally to clients.

This role is remote based in the United Kingdom.

The Senior Director will work closely with VDC Head(s) and all other relevant parties as applicable to define and plan the further strategy and growth of the Practice/Services and provide leadership to the International Service Leads (ISL) and Heads (where applicable) regarding:

• Strategic planning, implementation, and execution of the VDC services
• Developing, expanding, harmonizing, and promoting the Global VDC services
• Preparing business propositions for new / expanding Practice areas/Services

Evaluate service readiness and propose enhancements and solutions to mature the Practice/Services:

• Analysis & review of the global target service delivery model, gap analysis and recommendation to cover any gaps including identification of M&A targets / potential partners
• Define business technology needed for the Practice/Services, in close collaboration with relevant functions and in cross VDC settings; and proactively propose & support Digital solutions where applicable.

If applicable, contribute to the definition of PharmaLex cross-VDC service solutions:

• Work with the VDC Head, country VDC Heads and individual ISLs to define and develop the strategy for the respective practice area
• Communicate and implement the strategy for the respective practice area and service lines
• Provide operational leadership and guidance to the ISLs to help them to develop suitable global tools, support and communication processes
• Work with ISLs to develop and maintain global analytical / business intelligence tools for the VDC (e.g., skill matrix, capacity planning, practice/service oversight, metrics)
• Support the ISLs on preparation of request for proposals / request for information and in participation in Bid defense meetings and other client meetings

Together with VDC head and other stakeholders, develop and maintain a global (cross-VDC) pricing structure for the respective practice/service to establish a transparent and competitive approach across all local units:

• Act as an ambassador for a positive performance by educating and supporting the ISLs to think commercially and innovatively
• Interface for back-office functions with regard to business development / marketing activities, recruiting, finance and project management related activities
• To develop excellent relationships with all stakeholders including VDC heads, Country Heads, other Practice Area Leads, ISLs across all VDC practice areas, VDC employees

Critical qualifications, experience, ‘know-how’ and skills

• Degree in Life Science
• Excellent knowledge of applicable international legislation and regulatory framework
• Proven experience in assigned international practice/service
• Excellent interpersonal skills
• Familiar to work with international teams for global projects
• Excellent written and verbal communication skills
• Self-confidence and assertiveness
• Confidence to work alone as well as in a team
• Strategic, analytical and structured thinking
• Ability to assimilate and analyse information rapidly
• Ability to identify and offer solutions to problems in a pragmatic way
• Flexibility and adaptability
• Ability to adjust rapidly to new, unknown, challenging situations

Seniority level

Director

Employment type

Full-time

Job function

Business Development and Consulting

Industries

Pharmaceutical Manufacturing