Regulatory Submission and Project Management Specialist

Rhythm PharmaceuticalsBoston, MA

$72,000 - $108,000 / year

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Overview

Schedule

Full-time

Career level

Entry-level

Remote

Hybrid remote

Compensation

$72,000-$108,000/year

Job Description

Company OverviewRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.Opportunity OverviewIn support of our continued growth, we are looking for a Global Regulatory Submission Management Specialist to join our Global Regulatory Team. This is a highly visible role with excellent career development opportunities within Global Regulatory Affairs for motivated candidates. The position reports into the Global Regulatory Lead for one or more programs. Responsibilities and DutiesSubmission & Project Management

Responsible for management of asset-level global regulatory submission planning including annual reporting and ad hoc submissions for both development programs and post-approval life cycle management.
Responsible for the planning and tracking of routine and ad hoc US, EU, and Global regulatory submissions, monitoring the submission forecast and ensuring high quality, compliant and validated submissions to health authorities within required timelines.
Manages submission calendar, creates content plans for lifecycle and global submissions across multiple global applications, creates timelines and oversees responsibility matrices through cross-functional discussions, and tracks submission deliverables to maintain the target filing date.
Proactively communicates issues or delays related to the completion of planned submissions.
Liaises with cross-functional collaborators to gain alignment and ensure that submission requirements and timelines are understood.
Effectively manages multiple projects and competing priorities.

Regulatory Department Support

Maintains regulatory trackers for assigned programs, including submission calendar, archives of regulatory submissions, correspondence and commitments.
May assist in management of special projects as needed (e.g., oversight of system/process improvement projects).
Assist with regulatory inspection readiness activities.

Qualifications and Skills

Bachelor's degree preferred, scientific and/or computer science field preferred
At least 1 year of relevant pharmaceutical experience (or relevant internship experience within a graduate-level degree program)
Requires eCTD knowledge
RAC certification desirable
Knowledge of Veeva RIM Suite preferred
Experience with StartingPoint templates preferred
Working knowledge of the drug development process
Solid understanding of regulatory requirements and submission processes
Excellent collaboration and time management skills; ability to handle multiple work assignments concurrently; ability to coordinate and prioritize conflicting deadlines
Strong organizational skills with detail-oriented focus
A demonstrated ability to work with minimal supervision
Excellent verbal and written communication skills

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs.This role may involve some travel.The expected salary range for this position is $72,000 - $108,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.More about Rhythm We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are:

We are committed to advancing scientific understanding to improve patients’ lives
We are inspired to tackle tough challenges and have the courage to ask bold questions
We are eager to learn and adapt
We believe collaboration and ownership are foundational for our success
We value the unique contribution each individual brings to furthering our mission

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law. Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.

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FAQs About Regulatory Submission and Project Management Specialist Jobs at Rhythm Pharmaceuticals

What is the work location for this position at Rhythm Pharmaceuticals?

This job at Rhythm Pharmaceuticals is located in Boston, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Rhythm Pharmaceuticals?

Candidates can expect a pay range of $72,000 and $108,000 per year.

What employment applies to this position at Rhythm Pharmaceuticals?

Rhythm Pharmaceuticals lists this role as a Full-time position.

What experience level is required for this role at Rhythm Pharmaceuticals?

Rhythm Pharmaceuticals is looking for a candidate with "Entry-level" experience level.

What is the process to apply for this position at Rhythm Pharmaceuticals?

You can apply for this role at Rhythm Pharmaceuticals either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.