Senior Manager, Regulatory Affairs – (Multiple Positions Available)
Boston, MA
Full Time
Experienced
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.
Responsibilities and Duties
Qualifications and Skills
Employer Contact: Deb Lewandowski, VP, People and Culture, [email protected]
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:
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.
Responsibilities and Duties
- Responsible for working with a cross-functional collaborative team to assist in regulatory strategies and initiatives for assigned programs and assist in the effective management and timely execution of regulatory filings, maintain compliance with global regulatory standards and commitments, provide regulatory guidance and oversight, and help improve internal standards and systems.
- Represent Regulatory Affairs on multi-disciplinary project teams and provide regulatory guidance on development plans.
- Prepare regulatory development plans for assigned projects and establish/manage regulatory timelines.
- Translate user requirements into clear, detailed functional requirements.
- Help to ensure effective and timely execution of regulatory filings in compliance with relevant standards and commitments.
- Author, prepare, review, and submit Module 1, Module 2, and/or Module 3 documentation for varied regulatory filings such as NDA, ANDA and IND, including post-approval and labeling supplements (PAS, CBE-30, CBE-0).
- Assist in the planning, preparation, and review of content for submissions to Regulatory Agencies (eg, INDs, NDAs/supplemental NDACTAs, meeting requests, IND safety reports, annual reports) and coordinate responses to Regulatory Agency requests.
- Assist with meeting request/briefing document preparation, responses to pre-meeting comments, preparing teams for meetings and teleconferences with Regulatory Agencies.
- 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/guidelines 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
- Bachelor's degree in Pharmacy, Life Sciences, Regulatory Affairs or a closely related field.
- 4 years of regulatory experience in drug development and product registration activities within the pharmaceutical or biotech industry. The stated experience must include the following:
- Working on multiple phases of drug development; and
- Following regulatory requirements (regulations, directives, and guidance/guidelines) for the development and registration of drug products in multiple ICH regions.
- Eligible to telecommute from a home office within normal commuting distance of the Boston, MA office
Employer Contact: Deb Lewandowski, VP, People and Culture, [email protected]
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
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