Senior Director- Regulatory CMC- Drug/ Device

Radius Health

Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the "EEO is the Law" poster. Click here to navigate Radius Health's Pay Transparency Policy.

Position Title: Senior Director- Regulatory CMC- Drug/ Device

Job Category: Quality

Req ID: SENIO002373

Schedule: Full Time

Posted:Mar 17, 2025

Job Details
Description

Radius Health is a global biopharmaceutical company focused on bone health and osteoporosis. Our team works collaboratively and relentlessly to advance our therapies with the goal of improving the lives of patients, their families, and their caregivers. We are currently recruiting for a Senior Director, Regulatory CMC-Drug/Device.

Job Summary:

Develop and implement Global Regulatory and Chemistry, Manufacturing and Control (CMC) Regulatory strategies for products, including drug/device combination products, from development through marketing approval for the US, EU, and other markets. The incumbent will be responsible for regulatory leadership, preparation and support of US BLA and NDA regulatory submissions, and ensuring compliance to all applicable regulations and standards, with focus on CMC and with specific expertise in the device component of submissions and on drug/device combination product requirements. This is a key leadership role for both the regulatory and technical teams. This is a remote position, and the ideal candidate will be located in Northeast US.

Essential Responsibilities:
Prepares and manages CMC Regulatory content for submissions in all applicable regions, ensuring high quality and timely submissions.Submissions may include BLAs, MAAs / NDAs - Module 3 and QOS content, supplemental submissions, and responses to health authority questions, in support of drug product or drug/device combination product development or commercialization.Supported activities may include companion diagnostic development, DP and/or drug/device combination product development, validation and commercialization, Design Control strategy and documentation, and Human Factors validation testing.CMC Regulatory and Combination Product Subject Matter Expert to Project teams and/or CMC sub-teams.Leads regulatory strategy for all activities with Regulatory impact for assigned projects, creating and maintaining CMC Regulatory strategy documents.Maintains expert knowledge in US and international pharmaceutical and combination product regulations and provides proactive regulatory intelligence, particularly in quickly changing and/or highly competitive areas, in all relevant territories (e.g. US, EU, JP, ICH), with a particular focus on device regulations.Key contact for Radius' drug delivery/device partners.Accomplishes department objectives by managing and leading team members.Develops and maintains team members by effectively recruiting, selecting, orienting, and training employees.Works with team members to develop growth opportunities within the organization.Continuously evaluates team performance and provides coaching to build skills and knowledge.
Experience and Qualifications:
Minimum of BS in life sciences, engineering, or equivalent required.RAC certification and/or other regulatory certification is a plus.10+ years in the pharmaceutical industry, including drug/device combination product development and commercialization experience.Experience with regulatory requirements and submissions for companion diagnostics and medical devices.Experience in developing and submitting successful BLNNDA submissions with a thorough understanding of the drug development process, FDA regulations and ICH guidelines, with demonstrated expertise in drug/device combination products.Proactively advocates working together in the spirit of openness, honesty, and transparency that encourages collaboration, respectful interactions, and trust.Previous experience in leading regulatory teams.
Work Environment:

The work is performed primarily in a remote office environment with occasional required in person office work, meetings, and/or travel. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee is required to utilize audio visual programs for frequent meetings and discussions with fellow employees, vendors, outside agencies and/or customers. The employee may lift and/or move up to 10 pounds occasionally.

Equal Opportunity Employer Statement

Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender

identity, national origin, age, disability, genetics, or protected veteran status. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

At Radius Health, Inc. we have a commitment to our culture and to our employees' well-being and work-life balance. We support this mission by offering a compensation package with medical, dental and vision benefits. We also provide parental leave, a 401K match and a generous time off plan including two company shutdowns; the week of July 4th and the last week in December. We are proud to provide a competitive salary range for the Senior Director, Regulatory CMC-Drug/Device role, which is $243,000 - $280,000.

EOE:
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Equal employment opportunity, including veterans and individuals with disabilities.

PI265761375