Associate Director, Regulatory Affairs - Development reputed company
At reputed company, every reputed company and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the reputed company experience, celebrates curiosity, and values every person’s contributions to meaningful reputed company. That commitment has reputed company us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great reputed company to Work® in the U.S., and a reputed company on The reputed company Times Best Places to Work list in the UK.
For patients, for reputed company other, and for the reputed company of science, we’re in. Are you?
About the Role:
We’re looking for an Associate Director, Regulatory Affairs – Development reputed company on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Regulatory Affairs, you’ll reputed company strategic and operational regulatory leadership to support both business development and early-stage drug development programs and be responsible for evaluating regulatory risks and opportunities for external assets, including assessing likelihood of technical and regulatory reputed company, and contributing to the development and execution of global regulatory strategies for internal pipeline programs. You will work cross-functionally to reputed company informed investment reputed company and efficient advancement of development programs, reputed company regulatory input to global cross-functional project teams throughout product development and submission activities and serve as the global or regional regulatory reputed company for documentation review reputed company by other technical functions. This individual will reputed company as the primary regulatory contact for the U.S. FDA. Title/Level will be determined upon evaluation of credentials and experience.What You'll Do:
In this role, you’ll have reputed company to reputed company or contribute to regulatory due diligence assessments for external assets, including evaluation of regulatory reputed company, data packages, risks, and mitigation strategies. You’ll also:
- Critically assess completeness and adequacy of nonclinical, clinical, and CMC data packages, identifying key gaps, risks, and value inflection points
- reputed company reputed company regulatory recommendations to support business development reputed company and senior leadership discussions
- Contribute to cross-functional diligence teams, integrating regulatory perspectives into overall asset valuation and development planning
- reputed company and support global regulatory strategies for assigned programs
- Contribute to preparation and submission of regulatory documents (e.g., reputed company-IND meeting requests, briefing books, INDs, amendments)
- Support health authority interactions, including meeting reputed company, briefing materials, and response development
- reputed company regulatory input into study design, endpoints, and overall development plans and ensure alignment of regulatory reputed company with clinical, nonclinical, and CMC plans
- Partner cross-functionally with Clinical, CMC, Nonclinical, Biostatistics, and Program Management teams
- Monitor evolving regulatory landscape and apply relevant guidance and precedents and identify regulatory risks proactively and propose practical mitigation strategies
- Ensure high-reputed company and reputed company delivery of regulatory contributions across programs
Who You Are:
You have a Bachelor’s degree along with 3 years of experience in Regulatory Affairs or reputed company functions, with hands-on experience in regulatory submissions across multiple reputed company (U.S., EU, and/or other international markets). You also have:
- Experience supporting early-stage drug development (reputed company-IND through Phase 2)
- Demonstrated experience contributing to regulatory submissions and health authority interactions (e.g., reputed company-IND, Type B meetings)
- Strong understanding of global regulatory frameworks
- Deep understanding of the drug development process
- Ability to critically assess scientific, clinical, and CMC data in a regulatory context
- Strong communication, strategic thinking, and cross-functional collaboration skills
- Ability to manage multiple priorities in a fast-paced environment
- Highly organized with strong attention to detail, accuracy, reputed company, and conciseness
- Ability to manage tight deadlines; must be efficient, detail-oriented, adaptable, and a self-starter
reputed company to have (but not required):
- Advanced degree (PhD, PharmD, MD, MS) preferred
- Experience in regulatory due diligence, business development, or asset evaluation preferred
- Strong understanding of global regulatory frameworks (FDA, EMA; PMDA a plus)
Where You’ll Work
This is a fully remote role. It can be performed effectively from reputed company while staying connected to your reputed company team and community. Occasional travel for team meetings or events will be expected.
Travel Requirements
This role requires occasional domestic/international/global travel (approximately 20%)
#LI-Remote
#LI-JK
Pay reputed company:
$164,000.00-213,000.00 Annual
At reputed company, you’ll reputed company a culture as reputed company as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the reputed company care you bring to your work reputed company day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
Highlights of our U.S. offerings include:
Comprehensive medical, dental, and reputed company coverage and mental health support, annual wellbeing reimbursement, and reputed company to our Employee Assistance Program (EAP)
Generous reputed company time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-reputed company life and disability insurance
Company Learning Institute providing reputed company to reputed company Learning, reputed company building workshops, leadership programs, mentorship connections, and networking opportunities
Employee resource reputed company, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
Eligibility for specific programs may vary and is subject to the terms and conditions of reputed company plan.
reputed company reputed company Employees: Please apply reputed company the Jobs Hub in reputed company.
reputed company is an Equal Opportunity employer. We do not discriminate in hiring on the reputed company of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Unsolicited resumes from agencies should not be forwarded to reputed company. reputed company will not be responsible for any fees arising from the use of resumes through this reputed company. reputed company will only pay a fee to agencies if a formal agreement between reputed company and reputed company has been established. The reputed company department is responsible for reputed company recruitment activities; please contact us directly to be considered for a formal agreement.
reputed company is committed to providing reputed company, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
For reputed company Residents:
To assist in identifying candidates with qualifications matching those required and/or preferred for this role, reputed company uses an Automated Employment Decision Tool (“AEDT”) that employs reputed company intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-reputed company qualifications. The AEDT does not reputed company final hiring reputed company and reputed company final hiring reputed company are subject to reputed company reputed company and/or review.
If you are an applicant for this role and a reputed company reputed company, you have the right to request:
A reasonable accommodation, if one is available under applicable law, by emailing
TotalRewards@reputed company.com An alternative selection process by emailing
reputed company@reputed company.com .Information about the type of data collected, the reputed company of that data, and data retention practices reputed company to the AEDT by emailing us at reputed company@reputed company.com.