Manager, Regulatory Liaison Job

Manager, Regulatory Liaison-REG002716

Description

The Regulatory Affairs International Headquarters (RAI HQ) Manager position is a broad role encompassing all aspects of regulatory strategy including clinical efficacy, safety, Chemistry, Manufacturing and Controls (CMC), risk management, and labeling. He/she has direct responsibility for a portfolio of products that generally ranges across all phases of development and includes mature products. The Manager reports to a Director in RAI HQ.

The Manager Scientist will have responsibility for an assigned portfolio of products. The individual will have responsibility for leading and strategically driving results on assigned products and projects through alignment and prioritization with Department management and across stakeholders.

Specific responsibilities (with coaching and managerial oversight) include:

- Create and drive implementation of a Rest of World (ROW) regulatory strategy for assigned new products to optimize time to approval in collaboration and alignment with the product team.

- Create and drive execution of regulatory strategy to support lifecycle management of in-line (i.e., mature) products.

- Occasionally review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues.

- Regulatory review of labeling and responsibility for the strategy and release of supplemental safety and efficacy supplements to update the label.

- Collaborate and communicate with Country Regulatory Leads, Regional Leads, Regional Liaisons, other functional areas within Global Regulatory Affairs and Clinical Safety, MRL and across Divisions with GHH and MMD to ensure alignment around a common set of priorities and objectives for ROW filings and lifecycle management activities.

- Support for Clinical Trial Applications (CTA’s) in Phase I-III, Product, Registration and Launch (PR&L) filings and post filing activities.

- Participate in business process space forums and other organizational initiatives and may represent RAI HQ on cross-functional/cross-divisional teams

- Act as the Global Regulatory Team (GRT) Lead for assigned products

- May have some agency interactions such as facilitating responses to agency queries, Pre-Submission Meetings (PSMs), FDA communications, etc.

Qualifications

Education:

- B.S. or B.A. in Pharmacy, Biological Science, Chemistry, Nursing or related discipline.

Required:

- At least 4 years of relevant experience in the pharmaceutical industry, OR an M.S. or higher plus 2 years of relevant experience.

- Must have excellent communication skills (both oral and written).

- Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.

- Flexibility and negotiating skills are required.

- Strong scientific and analytical skills.

Preferred:

- Prior regulatory experience

(US/Puerto Rico Only) In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. If you have any questions, please contact your HRBP or Staffing Consultant.


Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Regulatory Affairs Liaison

Job Title:Sr. Scientist, Regulatory Liaison

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 2

Company Trade Name:Merck