Director, Regulatory Strategy (Pediatrics)

The Role

The Director, Regulatory Strategy will be responsible for developing regulatory strategies to support pediatric clinical development plans, working cross-functionally across the organization.

What You Will Do

• Develop and execute global regulatory pediatric strategy including the potential to accommodate expedited development needs
• Provide global regulatory expertise in support of the development, review, and approval of cross-functionally developed strategies and documents intended to enable clinical trials and marketing authorizations for pediatric programs
• Plan, lead, develop, and review regulatory submissions, such as clinical trial applications, marketing applications, and life-cycle management submissions for pediatric programs
• Plan and lead health authority interactions, as needed, including the development and/or review of associated documents
• Ensure adherence to current regulations associated with regulatory activities

Qualifications

• Bachelor’s degree in life-sciences or related scientific discipline required; advanced degree (PhD, PharmD, or MS) preferred
• 10+ years of experience in Regulatory Affairs within the biopharmaceutical industry
• 7+ years of experience with pediatric plans (both in US and EU)
• Experience leading preparations for health authority interactions and development of briefing documents
• Strong knowledge of drug development, FDA, EMA and ICH guidelines and regulations
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment
• Positive attitude, energetic and proactive
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others

Benefits

Deliberate Development. Your professional growth as one of our top priorities.

We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.

Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.

Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.

Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.

Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.

Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.