Director, Regulatory Pre-Award Strategy - Europe/Canada- Remote

Worldwide Clinical Trials; Canada; Remote; CAD 130,000 - 180,000; Full time

Job summary

Worldwide Clinical Trials in Canada is seeking a Regulatory Pre-award Strategy Director to steer global regulatory activities, design strategies for bid defenses, and oversee pre-award deliverables. You will lead cross-functional collaboration with Regulatory, Therapeutic Area leads, and Business Development to craft competitive proposals.

This leadership role requires extensive Regulatory Affairs experience, travel readiness, and the ability to train and mentor team members across the

Qualifications

• Deep knowledge of Regulatory Affairs in Pharma, CMC or Preclinical.
• Ability to define and develop regulatory strategies for global bids.
• Experience leading cross-functional teams in a matrix organization.
• Strong communication and negotiation skills with customers and internal stakeholders.

Responsibilities

• Direct regulatory pre-award activities and develop compelling bid defenses.
• Design and drive regulatory strategies for global start-up activities.
• Oversee proposal development and pre-award deliverables.
• Lead department training and coaching programs across roles.
• Collaborate with Regulatory, TA, Business Development, PM and Site Management.
• Ensure staffing projections and budgets meet pre-award targets.
• Represent the department in cross-organizational initiatives.

Skills

Regulatory affairs

Cross-functional collab

Leadership

Regulatory strategy

Travel readiness

Education

Life science degree

Allied health certification

Job description

Who We Are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

Who We Are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What The Regulatory Pre-award Strategy Director Does At Worldwide

This is a leadership role, accountable for directing business development and pre-award activities, developing them into compelling and competitive proposal offerings leading to bid defenses. Pre-award activities include designing and driving regulatory strategies, overseeing proposal development and approving pre-award deliverables. The role also requires designing and implementing a department-wide business development training and coaching program for various roles within the department.

What You Will 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 team leadership, Therapeutic Area leadership, Business Development, Project Management, Site Management and other functions to develop comprehensive pre-award site activation strategies
• Develop and implement a comprehensive department-wide training and coaching program in collaboration with internal stakeholders
• Train and coach department team members on pre-award activities to expand pre-award skills and increase flexibility when assigning qualified resources to pre-award work
• Achieve operational and financial performance 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 You Will Bring To The Role

• 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

Your Experience

• University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory, or laboratory technology) 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

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.