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Harmony Biosciences is recruiting for a Director, Regulatory CMC in our Plymouth Meeting, PA location. In this role you will closely interact cross-functionally to create high quality regulatory submissions that support product development strategy. This role will lead the authoring of clear, concise, and effective CMC documentation for clinical trial applications, IND submissions and amendments, briefing documents, NDA submissions and amendments, responses to agency queries and other communications with regulatory authorities; as well as advise on best practices and CMC regulatory strategy, planning and the preparation of CMC regulatory submissions to achieve timely approvals of initial marketing authorization applications and post-approval lifecycle changes.

Responsibilities include but are not limited to:

• Authors concise, and effective CMC documentation for clinical trial applications, IND submissions and amendments, briefing documents, NDA submissions and amendments, responses to agency queries and other communications with regulatory authorities.
• Manage planning, preparation, and internal review of CMC documentation for regulatory submissions.
• Manage preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) requirements and company standards.
• Ensure timely delivery of high-quality CMC documents while assuring all documents meet regulatory requirements and quality compliance.
• Attend project team meetings and provide CMC regulatory expert input to cross functional teams.
• Work closely with cross-functional teams for CMC strategy development and creation of CMC submission documents from early phase clinical submissions through marketing applications and post-marketing maintenance of applications.
• Support cross-functional teams related to overall product development and registration strategy.
• Articulate complex CMC regulatory CMC issues to project teams and external stakeholders to support global development and commercialization of drug candidates.
• Support and comply with procedures established by Regulatory Operations for electronic submissions and document archiving to ensure efficiency and traceability of all CMC regulatory documents.
• Facilitate review and cross-functional input on all technically complex CMC documentation for submission to regulatory authorities including process development, process validation, analytical method development, and analytical method validation supporting establishment of specifications and in-process, release and stability data and information appropriate to phase of development.
• Evaluate proposed manufacturing and quality changes for impact to ongoing and existing applications and provide strategic regulatory impact assessments and guidance for optimal implementation of changes.
• Manage interactions with FDA and other regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of clinical trial applications, marketing applications, amendments/supplements/variations, and other submissions that present CMC information.
• Develop and maintain excellent relationships with regulatory authorities, cross-functional teams, contract manufacturing organizations, and corporate partners.
• Support Quality Assurance in preparing and hosting audits and regulatory inspections.
• Maintains current understanding of the laws, regulations and guidelines pertaining to CMC/Quality information relevant to development programs.

Qualifications:

• Bachelor's Degree required
• 8+ years regulatory affairs experience within a pharmaceutical or biotech company required; 6+ years directly in CMC regulatory affairs.
• Demonstrated sound understanding of related fields i.e., manufacturing process, process development, analytical method development/validation, quality assurance with the ability to be creative and innovative in approach to new and diverse problem solving.
• Experience in preparation and submission of CMC documents in eCTD format, including response to agency questions and briefing books, is required with proven demonstration of high-quality regulatory writing.
• Strong knowledge of current Good Manufacturing Practices (cGMP), drug and biologics development regulations and guidelines including FDA and EMA guidelines.
• Proficient in the use of MS Office Suite, Outlook, Word, Excel, Power Point, Teams. Knowledge of Veeva RIM and eQMS a plus.

Physical demands and work environment:

• Travel is estimated to be 20% of the time, both domestic and international. Valid US passport is required or has the ability to obtain.
• While performing the duties of this job, the noise level in the work environment is usually quiet.
• The employee must occasionally lift and /or move more than 20 pounds.
• Specific vision abilities required by this job include: Close vision.
• Manual dexterity required to use computers, tablets, and cell phone.
• Continuous sitting for prolonged periods.

What can Harmony offer you?

• Medical, Vision and Dental benefits the first of the month following start date
• Generous paid time off and Company designated Holidays
• Company paid Disability benefits and Life Insurance coverage
• 401(k) Retirement Savings Plan
• Paid Parental leave
• Employee Stock Purchase Plan (ESPP)
• Company sponsored wellness programs
• Professional development initiatives and continuous learning opportunities
• A certified Great Place to Work® for six consecutive years based on our positive, values-based company culture

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Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com

Harmony Biosciences is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.