Vice President, Global Regulatory Science

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.

Preferred location is Waltham, MA or San Diego, CA. Will consider remote candidates.

What You'll Do:

The Vice President of Global Regulatory Science will serve as a key team player for an asset in development providing regulatory expertise and insight into the development plan resulting in competitive, complete, and on time submissions.

Responsibilities:

• Develop a global regulatory strategy which supports product (including delivery device and relevant medical devices) development, registration, and lifecycle maintenance globally. Ensure regulatory strategy is integrated into the development team plan.  Develop and implement innovative approaches and solutions, and drive acceleration strategies.  Identify and effectively communicate regulatory risks. 
• Initiate and maintain 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. Integrate information from the external environment, product specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust, innovative regulatory strategies and solutions.  Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment. Monitor upcoming and recent approvals of competitive development programs/plans. 
• Lead regulatory agency meetings, written communications, and serve as the point of contact for regulatory authorities.  Provide oversight of vendors should regulatory interactions be outsourced in a particular market.
• Determine and communicate submission and approval requirements and regulatory expectations.
• Generate regulatory documents and ensure the regulatory documents contain appropriate data/information based on regulator expectations and are clearly written.
• Execute high quality communications with FDA, other global regulatory bodies, and internal customers to articulate and ensure understanding of the regulatory strategy and complex issues.  

Required Qualifications:

• Industry related experience in regulatory affairs and/or drug development experience for 12 years 
• Travel expected (10-15%) 
• Experience in regulatory submissions and regulatory interactions in the US, EU, China and Japan 
• Previous regulatory or leadership assignments across multiple countries 
• Industry-related experience in regulatory affairs and/or drug development experience for 10 years 
• Demonstrated deep knowledge of the integrated drug development process
• Demonstrated ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion 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 

Education:

• Advanced scientific degree (i.e., PhD, MD, PharmD) or bachelor’s with at least 15 years of relevant drug development experience 

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.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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