Senior Director, Global Regulatory Affairs

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

The Senior Director of Global Regulatory Science will serve as a key team member for assets in development providing regulatory expertise and insight into the development plan resulting in competitive, complete, and on time submissions in Rest of World Markets including Japan.

Preferred location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities:

• Develop and implement a global regulatory strategy which supports development, registration, and lifecycle maintenance in ROW markets for early and late-stage development programs.   Ensure regulatory strategy is integrated into the program team plan.  


• Execute regulatory strategy by leveraging team expertise, as well as scientific, drug/device clinical development and knowledge from health authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory science. 


• Develop and implement innovative approaches and solutions, and drive acceleration strategies.  Identify and effectively communicate regulatory risks, offering contingencies and mitigations for various regulatory scenarios. 


• Interact directly with and lead regulatory agency meetings for designated markets.  Provide oversight of vendors should regulatory interactions and responsibilities be outsourced in a particular market.


• Serve as department point person for regulatory competitive intelligence.  Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment. Monitor upcoming and recent approvals of competitive development programs/plans. Share information with team members along with an assessment of potential impact.


• Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and regulatory strategy.  


• Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.  


• Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.  


• Will be provided organizational responsibilities such as labeling strategy, independent regulatory strategy and problem-solving assignments for ROW Markets, and other as needed assignments based on need and availability.  This is to ensure staff growth, development, flexibility and teamwork to achieve portfolio success.

Required Qualifications:

• 10+ years of relevant drug development experience


• Industry related experience in regulatory affairs


• Experience in international regulatory submissions and regulatory interactions


• Previous regulatory or leadership assignments across multiple countries 


• Demonstrated deep knowledge of the integrated drug development process


• Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes 


• Demonstrated ability to assess and manage risk in a highly regulated environment 


• Strong written, spoken and presentation communication 


• Demonstrated negotiation and influence skills 


• Willingness to travel between 10-15%

Preferred Qualifications:

• Experience in the GLP-1 space preferred

Education:

• Advanced degree (such as PhD, PharmD, MS, MBA) preferred

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

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