Company: Planet Pharma Staffing Limited
Location: Leiden, Netherlands
Closing Date: 17 Dec 16
Salary (£): On Application
Planet Pharma are recruiting for an Associate Director of Regulatory Affairs on behalf of our client, an international Pharmaceutical Company in the Netherlands!
Role: Associate Regulatory Affairs Director – International Pharmaceutical Company
Location: Leiden, Netherlands
Job Type: Freelance – 6-month contract (ASAP start)
Planet Pharma are recruiting for an Associate Director of Regulatory Affairs on behalf of our client, an international Pharmaceutical Company in the Netherlands. This is an exciting opportunity for an experienced Regulatory Affairs professional looking for a new contract opportunity in an innovative and growing company!
Applications from anywhere in the EU welcome!
This position plays a key role in the regulatory affairs department. Independently responsible for multiple regulatory functions and can be a member of one of several regulatory groups. Responsible for developing regulatory strategy for new assignments outside of existing regulatory frameworks, with management oversight; driving submission related activities and successfully executing regulatory strategies.
- Actively seeks out knowledge of overall corporate strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact corporate strategy directly by participating in global strategic planning within therapeutic area project teams.
- Provides regulatory expertise for New Product Planning and Licensing due diligence activities.
- Member of important project teams/task forces requiring the interpretation of applicable Regional and ICH regulations to ensure compliance.
- Sets direction for key operations and new initiatives. Works closely with other individuals/groups within Regulatory Affairs to influence others to ensure departmental consistency, and identifies options for risk discussions.
- Oversees submissions and compiles complex, strategic submissions for assigned projects. Ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Reviews regulatory submissions for accuracy, consistency and quality.
- Is considered a regulatory expert by global project teams/task forces and is accountable for developing and recommending regulatory strategy.
- Manages the preparation and review of registration packages to ensure effective data presentation and quality scientific data against regulatory requirements. Independently manages complex technical documents for preparation, review and submission to regulatory agencies. Independently determines the best way to position information in assigned regulatory submissions to maximize reviewability. Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision.
- Interacts with global health authorities on project related communications, including facilitating Divisional and committee meetings. Interacts with other companies such as contract manufacturers, external development partners, and other subsidiaries.
- Defines and implements regulatory strategies and priorities; revises regulatory strategy as necessary based upon scientific data, changes in the regulatory environment, global project direction, etc.
- Assists with ongoing training of Regulatory Affairs staff.
- Bachelor’s degree in scientific discipline; advanced degree preferred.
- Extensive previous pharmaceutical drug development experience, as well as managing staff.
- Recognized as an expert in regulatory aspects of pharmaceutical drug development involving undefined frameworks with technical complexity and broad scope.
- Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development.
- Significant regulatory affairs experience preferably involving direct contact with regulatory authorities; full knowledge of regulatory and ICH regulations and guidelines, and the ability to provide interpretations of that information to others. Proven record of successful submissions and negotiations with authorities in areas of CMC and product formulations. Regulatory experience in other therapeutic areas such as medical devices or biologics.
- Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to direct reports and others in the department as needed.
- Ability to communicate effectively and maintain effective working relationships. Must be able to positively influence department staff and other APGD groups.
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