Director, ECP Regulatory - Development Sciences
- Experience Level
The Director, ECP (Europe, Canada, Partner Markets) Regulatory Development Sciences will be responsible for developing and delivering innovative, breakthrough ECP Regional regulatory strategies for product development and approval, in alignment with the global/regional business strategy, across Europe, the UK, Canada, Switzerland, Australia and New Zealand.
This role will be responsible for leading a comprehensive approach to developing and executing integrated regional regulatory plans that account for the complex interplay between Global Health Authorities. You will represent the company with domestic and international regulatory authorities, vendors and corporate partners. Provide regulatory support for various departments, projects, and teams and at high level governance committees.
- Responsible for directing regional regulatory strategies for assigned projects and programs.
- Direct regional clinical and pre-clinical regulatory strategies.
- Support development of the clinical development plan from phase 1 through to registration.
- Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.
- Communicate regulatory guidance, options and tradeoffs to company personnel throughout the research and development process.
- Set strategic direction and leads regional regulatory submission process with submission teams, including marketing applications and core briefing packages.
- Advise on CTA submission strategy.
- Direct the organization and preparation of clear and effective submissions.
- Prepare and deliver effective presentations for external and internal audience.
- Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.
- Build and maintain excellent relationships with relevant regulatory agencies, incl. alliance partners while negotiating company position.
- Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
- Provide input to Regulatory Senior Management teams.
- Maintain a regional view as part of the whole regulatory team
- Take steps to actively improve interdepartmental communications
- Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations
- May have presence on external regulatory committees/trade associations
- BA/BS/University degree required, Life/Health Sciences preferred
- Significant experience within RA in the Pharmaceutical/Biotechnology industry
- Comprehensive knowledge of applicable regulations.
- Experience in interpretation of regulations, guidelines, policy statements, etc.
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
- Solid knowledge of GCPs and GLPs.
- Direct experience in interfacing with relevant regulatory authorities.
- Foster effective, positive interactions with regulatory agencies, and corporate partners.
- Ability to lead and influence project teams, committees, etc. to attain group goals.
- Demonstrate excellent leadership and communication skills.
- Ability to represent the department in project teams, committees and external meetings.
- Demonstrate strong organizational skills, including the ability to prioritize personal workload.
- 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. Experience leading multi-disciplinary teams.
- Well organized, detail oriented, effective written and oral communication skills.
- Supervisory/mentoring experience.
- Ability to guide, train, supervise and prioritize workload of direct reports if applicable.
- Computer literate