Associate Director, Regulatory Affairs - CMC Job - United States
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Under the guidance of a Global Regulatory Affairs - CMC Director, the Associate Director will primarily be responsible for working within a team to lead and execute change control assessments, developing and executing regulatory strategies, planning, tracking, authoring, reviewing and gaining approval for global post approval changes.
The Associate Director responsibilities include but are not limited to:
- Participation in the authorization process to prioritize submissions.
- In depth knowledge of global CMC guidelines regarding post approval changes.
- Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines.
- Development and execution of detailed, global regulatory strategies for submission and approval of post approval change documentation according to defined timelines.
- Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply.
- Lead authoring of clear, concise and effective global post approval submissions according to defined timelines.
- Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions.
- Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate.
- Participation in early and late development programs, as well as departmental and cross-functional efforts to improve CMC content or processes may also be required, as needed
- Occasional travel to manufacturing sites may be required.
- Bachelor’s degree, in a related discipline
- Minimum of 5 years of CMC experience (technical or regulatory)
- Proficient in M.S. Word
- Adept at use of assessment, planning and tracking systems
- Capability to work effectively in matrix organizational structures
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
- Experience with post approval changes in Biologics or Vaccines
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Job: Regulatory Affairs - CMC
Job Title:Assoc. Dir, Regulatory Affairs-CMC
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Number of Openings: 2
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Regulatory Affairs, Manager, Law, Compliance, Supply, Legal, Management, Operations