Kailera Therapeutics, Inc.
Associate Director, Global Regulatory Affairs
Waltham, Massachusetts · Director · Full-time
Sponsorship not specified$10k-$15kDetected 1 day ago
Clinical TrialsFDA RegulatoryLeadershipCommunicationCollaborationRegulatory Affairs
> stay_score
odds of building a lasting career here
15Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70
No strong sponsorship signal in the public record yet. In the full product we resolve the exact legal entity and show its filing history with a confidence score — treat as unverified until then.
Lottery odds assume a STEM candidate.
Personalize to your clock →> community_outcomes
No reports yet — be the first to help the next applicant.
About the role
- As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
- Actual pay may vary based on experience, skills, qualifications, location, and internal equity.
- We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown.
Responsibilities
- Serve as the regulatory representative on core teams, developing and planning regulatory submission strategies, coordinating the preparation of submissions to regulatory agencies, and conducting regulatory intelligence activities
- Respond to regulatory questions from various regulatory authorities, working in collaboration with subject matter experts in clinical development, safety, and other business partners
- Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs
- Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
Requirements
- Established working knowledge of regulatory guidelines and regulations (US and international)
- Demonstrated deep knowledge of the integrated drug development process
- Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
Nice to have
- Advanced degree preferred
- Bachelors degree with 10+ years of relevant drug development experience
- Advanced degree (such as PhD, PharmD, MS, MBA) with at least 5 years of relevant drug development experience
- Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
Compensation
- $155,000 - $190,000 USD
- For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting.
- Actual pay may vary based on experience, skills, qualifications, location, and internal equity.
- Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us.
- Stay updated on global regulatory guidance and regulations, communicating key updates to senior leadership and project team management to ensure compliance with all reporting requirements, including annual and periodic reports
Benefits
- 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.
Company info
- We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.
Visa & Work Authorization
- tive 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-rel
Apply directly at Kailera Therapeutics, Inc. →Create a free account for alerts like thisView Kailera Therapeutics, Inc. immigration profile
This listing is sourced directly from Kailera Therapeutics, Inc.'s careers page and normalized into a canonical job model.