Associate Director, Global Regulatory Affairs
Our client is a global biotechnology company. They have asked us to assist them in their search for an Associate Director
, Global Regulatory Affairs.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Directs global regulatory strategies for assigned projects and programs.
- Directs global life cycle management of products.
- Supports development of the late stage clinical development plan.
- Identifies and assesses regulatory risks associated with product development and defines strategies to mitigate risks.
- Provides regulatory guidance to company personnel throughout the research and development process.
- Establishes strategic direction and conducts global regulatory submission process with submission teams.
- Maintains the Core Data Sheet and conducts global labeling team meetings.
- Advises on global Clinical Trial Application submission strategy.
- Directs the organization in preparation of clear and effective submissions.
- Prepares and delivers effective presentations for external and internal audiences.
- Monitors and analyzes appropriate regulatory agency activities in areas of interest to the company and assess impact on programs.
- Mentors managers and guides direct reports in carrying out responsibilities.
- Coordinates activities and career development of direct reports.
- Builds and maintains excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
- Provides input to Senior Management Regulatory teams.
- Maintains a global view as part of the team.
- Takes steps to actively improve interdepartmental communications.
- Participates in and contributes to outside relevant conferences, including organizing and delivering presentations.
- Participates in external regulatory committees.
- Degree in Life Science or related discipline is required. Advanced degree preferred.
- Requires industry experience with technical management experience and Regulatory Affairs.
- Must have understanding of working on products in development relating to regulatory aspects of the project.
- Expert knowledge with respect to the respective regulatory landscapes in the US, EU, and Japan is required.
- Requires experience working with regulatory authorities.
- Must have experience in interpretation of regulations, guidelines, policy statements, etc.
- Involvement and skill in the arrangement of major regulatory submissions and supportive amendments is required.
- Must be able to promote effective, positive interactions with regulatory agencies.
- Requires the ability to lead and influence project teams to attain group goals.
- Demonstrated excellent leadership and communication skills are required.
- Requires proficiency to represent the department in project teams, committees and external meetings.
- Requires strong organizational skills, including the ability to prioritize personal workload.
- Must have strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.
- Strong sensitivity for a multicultural/multinational environment is required.
- Requires supervisory/mentoring experience.
- Expert knowledge and experience in gene therapy highly desirable.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.