Senior Director, Regulatory Affairs - Military veterans preferred

Job Details

Description

Radius Health is a global biopharmaceutical company dedicated to transforming the future for patient populations in bone health and related therapeutic areas. Our team works relentlessly to improve the lives of our patients, their caregivers, our communities, our partners, and each other. We live by our corporate values, and every employee has an unwavering commitment to contributing to our positive culture. We are currently recruiting for a Senior Director, Regulatory Affairs.

Job Summary:

The Senior Director, Regulatory Affairs provides global regulatory leadership to support development and commercialization of Radius products. This position is responsible for translating regulatory, scientific, technical, and business knowledge into effective implementation plans and broad product strategies spanning clinical and technical aspects. Additionally, responsible for ensuring the timing/sequencing of global regulatory milestones as well as the preparation, review, and evaluation of documents for submission to health care regulatory authorities. This role serves as a strategic partner to executive leadership and regulatory thought leader to cross-functional teams, providing regulatory guidance across Chemistry, Manufacturing and Control (CMC), nonclinical, and clinical.

Essential Responsibilities:

• Prepare and manage regulatory content for submissions in all applicable regions, ensuring high quality and timely submissions (e.g. annual reports, post approval CMC and labeling supplements, responses to requests for information, and administrative updates).
• Serve as a CMC Regulatory and Combination Product Subject Matter Expert to Project teams and/or CMC sub-teams.
• Author submission documents in RIM vault and upload all health authority correspondence.
• Work with external vendors and global partners to ensure submission needs are met.
• Provide regulatory impact assessments for all change controls.
• Actively engage with internal and external stakeholders to help shape science based regulatory decision making.
• Serve as a global regulatory team leader for Radius products.
• Act as a direct liaison between regulatory authorities and Radius.
• Serve as regulatory team member for Safety Review Teams.
• Provide regulatory support and review of Investigator Initiated Studies.
• Maintain expert knowledge in US and international pharmaceutical and combination product regulations and provide proactive regulatory intelligence, particularly in quickly changing and/or highly competitive areas, in all relevant territories (e.g. US, EU, JP, ICH).
• Continually identify and inform appropriate stakeholders on emerging trends, opportunities, and threats to ensure alignment with business objectives.
• Mentor team members enabling growth opportunities and foster a culture of integrity, excellence, and continued improvement within the RA organization.
• Perform other duties as required by the needs of the company and the Regulatory Affairs team.

Experience and Qualifications:

• Requires a BS degree or equivalent with a master’s degree or PhD preferred.
• 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 in maintenance of IND and NDA submissions with a thorough understanding of FDA regulations, ICH guidelines, and post approval labeling and CMC change requirements.
• Significant regulatory submission experience and direct interactions with regulatory agencies (US and ex-US).
• Experience in regulatory strategy reflecting US and international requirements.
• Experience with Veeva Vault platforms such as RIM and Quality Vault is a plus.
• Strong ability to influence both internal and external stakeholders.
• Proactively advocates working together in the spirit of openness, honesty, and transparency that encourages collaboration, respectful interactions, and trust.

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 4^th and the last week in December. We are proud to provide a competitive salary range for the Senior Director, Regulatory Affairs role, which is $243,000 - $280,000.