Principal Scientist, Regulatory Affairs International Job

Employer
Merck
Location
Gwynedd, PA, US
Posted
October 12 2017
Organization Type
Pharma
Principal Scientist, Regulatory Affairs International-REG003297

Description

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

The Regulatory Affairs International Headquarters (RAI-HQ) Principal Scientist position is a broad role encompassing all aspects of regulatory strategy, including Chemistry, Manufacturing and Controls (CMC), clinical, risk management and labeling. The position has dual responsibilities. The Principal Scientist provides guidance and oversight, leading a group of RAI HQ Liaisons who are responsible for the development and implementation of regulatory strategies for Rest of the World (ROW) countries for their portfolio. These portfolios may include products in any phase of development through registration and/or mature products. The Principal Scientist will also have their own portfolio of product(s). The individual will have responsibility for strategically driving results on assigned products and projects through collaboration and alignment with stakeholders. The position reports to the Therapeutic Area Lead in RAI-HQ for Cardiovascular, Endocrine and Neuroscience.

This self-motivated individual functions with a high degree of independence and imparts their knowledge not only to their direct reports but also to the department as a whole. His or her drug development expertise is leveraged within the department to provide advice to RAI-HQ Liaisons and further via committee or cross-functional /cross-divisional team representation and consultation.

Specific responsibilities include:

- Manage up 2-4 individuals who are responsible for product development stages including Clinical Trial Applications (CTAs) in Phase I-III, Product Registration and Launch (PR&L) filings, and post filing activities.
- Manage individuals that develop and implement regulatory strategy to support lifecycle management of In-line products.
- Create and drive implementation of the ROW regulatory strategy for assigned products.
- Review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues.
- Provide regulatory review of product labeling. Responsible for the strategy and release of supplementary safety and efficacy supplements to update the label.
- Collaborate with Regional Liaisons and Country Regulatory Leads and with other functional areas within Global Regulatory Affairs and Clinical Safety, Merck Research Laboratories, and across divisions (Global Human Health and Merck Manufacturing Division) to ensure that a common set of priorities and objectives are developed for ROW filings and for lifecycle management activities.
- Manage the liaison support process, including resourcing for project assignments, role definition and management of activities for specific products.
- Conduct all appropriate HR activities including managing performance, development planning; staffing and related people-management responsibilities for liaisons within areas of responsibility.
- Mentor team members and provide guidance on various aspects of Regulatory Affairs and their projects.
- Lead and drive organizational initiatives on behalf of the RAI-HQ Leadership Team and represent RAI-HQ on cross-functional/cross-divisional teams.

Qualifications

Education:

- Required:

- Bachelor’s degree in Pharmacy, Biological Science, Chemistry, Nursing or related discipline
- Preferred:

- A Master’s degree in a relevant discipline with at least 7 years of relevant experience in the pharmaceutical industry or a Doctoral level Degree (e.g., Ph.D, M.D.) with 6 years of experience.

Required:

- A minimum of 8 years of relevant experience in the pharmaceutical industry (regulatory affairs or clinical drug/biologic development).
- Ability to work effectively both independently and in a team environment, good organizational skills, proven ability to balance diverse activities for multiple projects.
- Prior regulatory experience across a diverse portfolio of products.
- The RAI-HQ Principal Scientist must have the background and proven ability to apply regulatory knowledge and experience to resolve complex regulatory problems and to lead teams to resolution of issues.
- Must demonstrate good critical and logical thinking with the ability to analyze and apply creative solutions to complex business and/or technical problems and to identify alternative solutions and implement recommendations for resolution within a variety of situations.
- Must have led or participated in interactions with Health Authorities, such as FDA, EMA, facilitated responses to agency queries and attended agency meetings.
- Must have excellent verbal and written communication and organizational skills, as well as the ability to effectively and successfully collaborate and lead.
- A thorough knowledge of drug development and global regulatory requirements including the structure and content of regulatory submissions is necessary.
- Must be a self-motivated, flexible and creative leader, able to prioritize, multi-task and work in a fast-paced and demanding environment and possess the ability to take ownership of a given assignment, proactively consulting other team members and other department representatives for information or guidance, as necessary.

Preferred:

- Prior people management experience.
- Experience managing team activities for multiple projects (with possible global exposure/impact) is a plus

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

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


Job: Regulatory Affairs Liaison

Job Title:Prin. 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: 1

Company Trade Name:Merck