What are the responsibilities and job description for the Associate Director, CMC Regulatory position at Kailera Therapeutics, Inc.?
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 Associate Director of RA CMC will support the development and execution of global regulatory CMC strategies. This individual will support the day-to-day regulatory activities of assigned products, identify and collect data needed to support filings, information request, and registration maintenance to enable commercialization of products that are developed to meet global regulatory requirements. Additionally, they will manage all regulatory CMC submission processes, timelines, tracking tools, archives and infrastructure as assigned.
Preferred location : Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).
Responsibilities :
- Responsible for multiple products and supports the regulatory affairs (RA) CMC lead in the development and execution of regulatory strategies
- Plan and execute global RA CMC submissions for clinical, commercial, and post-approval activities
- Define CMC content requirements for regulatory submissions per regulatory (FDA, EMA, ICH, etc.) requirements
- Ensure timely preparation of module 3 and CMC documents and hand-off to regulatory operations for submission
- Lead the preparation activities for meetings with Health Authorities on CMC related topics
- Contribute to the evaluation of change proposals for global regulatory impact and planned variations
- Assist with building out RA CMC processes and tools to support clinical and commercial applications
- Manage all RA CMC documents in the regulatory information management systems
- Oversee copyediting, finalization, and approval of module 3
Required Qualifications :
Education :
Benefits of Working at Kailera
In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.
At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.
Salary Range
160,000-$200,000 USD
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.
LI-Hybrid
Salary : $160,000 - $200,000
