What are the responsibilities and job description for the Principal Scientist/Director, Regulatory Affairs-CMC (Chemistry, Manufacturing & Controls) position at Merck?
Merck Principal Scientist / Director, Regulatory Affairs-CMC (Chemistry, Manufacturing & Controls) - Honolulu, Hawaii
As the Director / Principal Scientist in Devices and Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You will spearhead regulatory activities for Devices and Drug-Device Combinations (DDDC), ensuring compliance with domestic and international regulations and guidance. This role includes the comprehensive preparation and submission of combination product sections for both commercial and investigational products, such as pre-filled syringes and autoinjectors.
Primary responsibilities include, but are not limited to :
- Serve as the Regulatory Project Lead for assigned device and combination products, guiding cross-functional teams to ensure regulatory compliance throughout development and commercialization. Mentor team members while driving project timelines and fostering a collaborative environment.
- Maintain in-depth knowledge of global device and drug / biologic-device combination product guidelines and policy regarding IND / CTA, original NDA / MAA, agency background packages, post-approval submissions / variations, 510(K)s, CE markings.
- Lead the development, communication, and review of Regulatory Strategies and execute on various deliverables for submission and approval of complex INDs, BLAs, original NDA / MAA, agency background packages, post-approval submissions / variations, and replies to health authority questions according to defined timelines.
- Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy, and completeness of submissions.
- Partner with Device Development, Device Quality, and other Drug stakeholders to communicate and align on new regulations and requirements to ensure internal procedures and processes are compliant for the combination product. Participate in activities and teams related to device and combination products.
- Provide evaluations of regulatory state of affairs of any devices and combination products, for due diligence of potential suppliers, partners, or acquisitions.
- Careful planning, tracking, and communicating regarding submissions and approvals to support continued product supply.
- Participate in early and late development programs, as well as departmental and cross-functional initiatives aimed at improving combination product content or processes, as needed.
- Manage or mentor junior team members as needed.
Education :
Required Experience and Skills :
Leadership Skills :
Preferred Qualifications :
US and Puerto Rico Residents Only :
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
U.S. Hybrid Work Model :
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
Expected US salary range :
181,600.00 - $285,800.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
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Salary : $181,600 - $285,800
