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Principal Scientist, Regulatory Affairs International (Director) Job

Job Details

Principal Scientist, Regulatory Affairs International (Director)-REG002541

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. 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.


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.

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 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 their own 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.

- Lead and resolve complex quality and compliance issues

- Collaborate and be the point of contact regarding pre-qualification of World Health Organization filings for certain 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. They 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. They will have led or participated in interactions with Health Authorities, such as FDA, EMA, facilitated responses to agency queries and attended agency meetings. They must have excellent verbal and written communication and organizational skills, as well as the ability to effectively and successfully collaborate and lead. Experience managing team activities for multiple projects (with possible global exposure/impact) is a plus. A thorough knowledge of drug development and global regulatory requirements including the structure and content of regulatory submissions is necessary. Quality and Compliance investigation experience is preferred. They 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. International travel will occasionally be required.

Qualifications

Education:

- A Bachelor’s Degree in Pharmacy, Biological Science, Chemistry, Nursing or related discipline

Required:

- A minimum of 8 years of relevant experience in the pharmaceutical industry.

- The ability to work effectively both independently and in a team environment, good organizational skills, proven ability to balance diverse activities for multiple projects.

- Ability to travel internationally when needed.

Preferred:

- Experience in regulatory affairs and/or clinical drug development is preferred.

- Experience with quality and compliance investigations is 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 a minimum of 6 years of experience.

- Prior people management experience.

- Prior regulatory experience across a diverse portfolio of products.

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 staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​



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

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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