About this role
Job title: Director, Regulatory Pre-Award Strategy - Europe/Canada- Remote
About the Role This is a leadership role responsible for directing regulatory pre-award strategy and business development activities across Europe and Canada. The director will design regulatory strategies, oversee pre-award deliverables, and develop a department-wide training program to enable competitive proposals and successful bid defenses.
What You'll Do
- Have and apply knowledge of global start-up and regulatory activities to pre-award customer deliverables, resulting in a differentiated advantage for bid defense and award
- Attend and provide leadership in bid defense meetings and presentations
- Collaborate with Regulatory, Therapeutic Area, Business Development, Project Management, Site Management and other functions to develop comprehensive pre-award site activation strategies
- Develop and implement a department-wide training and coaching program in collaboration with internal stakeholders; train and coach department team members to expand pre-award skills
- Achieve operational and financial targets related to proposal budgets and strategies
- Provide department resource projections and coordinate with the resourcing team to ensure pre-award staffing plans and forecasts are accurate and adequate
- Proactively interact cross-organizationally to develop and learn about emerging business, regulatory, therapeutic, and operational strategies that improve service to our internal and external customers
- Instill confidence in our customers during the proposal and bid process through knowledgeable and accurate communication of our startup strategy, including global / country regulatory requirements
- May help develop and implement cross-functional initiatives for continuous process and quality improvements
- May have line management responsibilities
What We're Looking For
- Demonstrated strong ability to define, organize, and develop complex Regulatory Affairs strategies into effective customer deliverables
- Strong ability to collaborate effectively among multiple functions and personalities to achieve organizational goals
- Demonstrated strong experience in effectively persuading internal and external customers and engaging in difficult conversations with desired results
- Demonstrated ability to manage activities and people in ambiguous and time-sensitive situations
- Strong experience in Regulatory Affairs is required, and experience with at least one cross-functional department, such as Regulatory Compliance, Feasibility, Site Management, Project Management, or Patient Recruitment, is preferred
- Interest and adaptability to drive innovative solutions for our customers, such as with decentralized clinical trials, remote and local home healthcare models, and direct-to-patient technologies
- Aptitude or proficiency in using and learning digital and software systems
- University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities
- Minimum of twelve (12) years of global clinical pharmaceutical industry experience, including 3 years of demonstrated skills and competency in managing teams in a global environment
- Experience in Regulatory Affairs in Pharma, CMC and/or Preclinical (Toxicology) knowledge
- Experience in Scientific advisory support & briefing packages prep
- Deep knowledge of the US & Global regulatory landscape is a plus
- Demonstrated ability to inspire effective teamwork and motivate personnel within a matrix system
- Available for domestic and international travel, including overnight stays; valid passport
- Fluent in local office language and in English, both written and verbal
- Broad knowledge of the drug development process and client needs
Nice to Have
- Deep knowledge of US & Global regulatory landscape is a plus
Compensation & Benefits
- Not disclosed in the posting