Associate Director, Regulatory Affairs

Company Overview Rhythm 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 Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development and delivery of science-based, solution-oriented and internally aligned regulatory strategies for the program(s) under your accountability.

You will lead the regulatory strategy and initiatives for your assigned programs.

By joining our growing and dynamic regulatory affairs team, you’ll be responsible for the effective management and timely execution of regulatory filings, maintaining compliance with global regulatory standards and commitments.

You will provide regulatory guidance and oversight and improve internal standards and systems.

Key accountabilities include providing technical and procedural regulatory guidance and strategy to key internal stakeholders to advance the development, commercialization and life cycle of Rhythm products.

This role reports into the Director, Global Regulatory Affairs.

Responsibilities and Duties Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic regulatory guidance on development plans Prepare regulatory development plans for assigned projects and establish / manage regulatory timelines Ensure effective and timely execution of regulatory filings in compliance with relevant regulatory standards and commitments Lead the planning and authoring of content for submissions to Regulatory Agencies (eg, INDs, CTAs, meeting requests, briefing documents, Pediatric Investigation Plans, annual reports) and coordinate responses to Regulatory Agency requests May serve as the liaison between the company and Regulatory Agencies for assigned projects Develop and maintain knowledge of US, EU and ROW regulations as appropriate for the assigned program(s) Help keep cross-functional team members apprised of new regulations, standards, policies and guidance issued by Regulatory Agencies that may impact the company Perform literature searches, prepare reports and assemble documentation to support project teams as required Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents Participate in initiatives aimed at improving internal standards and systems Qualifications and Skills BS or graduate degree in life sciences preferred 8+ years of Regulatory Affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development – both big and small company experience is preferred Demonstrated experience with regulatory programs for products to treat rare diseases and / or unmet medical needs (e.g., orphan products, fast track, breakthrough therapies, PRIME) Strong FDA and EMA experience required Full functional knowledge of regulatory requirements (regulations, directives and guidance / guidelines) pertaining to the development and registration of drug products in multiple ICH regions Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box; preference for demonstration of such within rare disease programs Ability to set priorities, work independently, deliver results in a timely manner and adapt and react to new information or changing priorities Strong organizational and planning skills, and ability to communicate effectively and efficiently to multiple audiences 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.

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.   Powered by JazzHR