Senior Manager, Regulatory Project Management

Harmony Biosciences is recruiting for a Senior Manager, Regulatory Project Management in our Plymouth Meeting, PA location. In this role you will be responsible for leading and coordinating regulatory projects to ensure timely and compliant submissions. This role serves as a key liaison to shape, drive and execute the regulatory project timelines and strategies; as well as engage with other stakeholder departments to assure timely execution of programs aligned with regulatory submission strategies, applicable regulations and company objectives.

Responsibilities include but are not limited to:

• Manage regulatory project timelines from initiation through completion, including for INDs, NDAs, Orphan Drug Designations, and global submissions.
• Communicate and track regulatory project timelines, milestones, and priorities to align project stakeholders and team members.
• Manage regulatory projects including tracking submission deliverables, creating status reports and maintaining risk logs.
• Collaborate cross-functionally with R&D, Quality, Manufacturing, and Pharmacovigilance teams to ensure regulatory compliance throughout the product lifecycle.
• Develop and author SOPs related to regulatory affairs or procedures for submissions.
• Assist in maintaining regulatory and medical writing systems and tools, such as shared drives and Veeva RIM.
• Assist with budgeting and contracting activities for programs and projects.
• Maintain compliance with global regulatory standards and company policies.
• Perform other duties as assigned.

Qualifications:

• Bachelor's Degree required in related field
• 6+ years of Regulatory experience in the biotech/pharmaceutical industry required
• Working knowledge of CTD/eCTD format and regulatory submission requirements required
• General knowledge and application of common regulatory submission tools/eCTD software, MS Word, Word templates, Adobe Acrobat, SharePoint, Veeva Vault RIM, and standard Office tools.
• Demonstrated ability to function independently with minimal guidance while simultaneously covering multi-varied project responsibilities
• Strong verbal and written communication skills with the ability to communicate with colleagues, business partners, stakeholders and upper management across varied styles and cultures

Physical demands and work environment:

• Domestic travel is estimated to be 5% of the time for this position.
• While performing the duties of this job, the noise level in the work environment is usually quiet.
• Specific vision abilities required by this job include: Close vision.
• Manual dexterity required to use computers.
• 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 seven 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.

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