Accessibility Links

Manager Regulatory Affairs

  • Job reference: 931119
  • Location: Haarlem, North Holland
  • Salary: Negotiable
  • Job type: Temporary
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 11/08/2020

Main purpose of the role

Purpose of Role

To provide technical analytical subject matter expertise during development, submission and approval stages of (external) sterile complex products to support the development of new products in line with agreed timelines, regulatory standards and best practices.

Key Results Areas

Responsibility for leading the analytical development, optimization, risk analysis and maintenance of the analytical part of the CMC plan (activities and timelines) and ensuring proper integration and alignment with overall project plan with Project Manager.

To define, design, and review experimental analytical work and reports ensuring best practices are applied to achieve the project plan and milestones;

To research methodologies, processes, patents and products to support product development.

To perform all work activities within the required guidelines to ensure compliance with regulatory authorities;

Contact with Others

Internal global group project team members

External project teams

Line management

Knowledge, Skills and Abilities

cGLP, cGMP regulatory requirement

Knowledge of Pharma product, development processes

Knowledge of statistical techniques

AQbD/PAT

Good technical writing skills and verbal communication

Project management

Technical leadership

Planning & organising

Problem solving/decision making

Qualifications and Accreditations

Degree qualified in Analytical Chemistry, Pharmaceutical Chemistry, Pharmacy or related subject

With proven in pharmaceutical industry

Competencies

- Collaboration ('Getting it Done Together') - The ability to work effectively with peers,

partners and others, to positively impact performance

- Planning & Organizing ('Getting it Done Together') - Adopts a structured approach,

establishes plans, priorities and goals that are clear and logical; Organizes resources.

- Drive & Resilience ('Getting it Done Together') - Demonstrates drive and persistence to meet and exceed objectives; remains positive in challenging situations and recovers quickly from setbacks.

- Effective Communication ('Getting it Done Together') - Communicates clearly to others and ensures understanding. Adjusts style of communication appropriately to the audience.

- Leading Others (supervisor only) ('Leading the Way') - The ability to empower, grow, develop and inspire high performing teams and individuals.

- Change & Adaptability ('Creativity Where it Matters') - The ability to recognize and act upon change as a necessity to achieve goals.

- Analytical Thinking & Problem Solving ('Creativity Where it Matters') - Analyses information effectively; identifies the causes of problems and provides realistic and practical solutions to address them.


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

Similar jobs
Quality Control Technician III
  • Salary Negotiable
  • Job type Contract
  • Location Haarlem, North Holland
  • Description Orion Group are currently recruiting a Quality Control Technician III Inhalation Capsule drug products, on behalf of one of our Multinational Pharmaceutical Clients based in the North of Holland