Associate Principal Scientist, Regulatory Affairs International Job

Associate Principal Scientist, Regulatory Affairs International-REG002613

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 Associate 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 Scientist has direct responsibility for a portfolio of products in all phases of development through registration and mature products. The individual will have leadership responsibility for an assigned portfolio of products, and for strategically driving results on assigned products and projects through alignment and prioritization across stakeholders.

This highly enthusiastic, self-motivated individual functions with a high degree of independence and imparts their knowledge into the department as a whole. They must demonstrate the ability to think laterally as well as vertically by looking at how issues potentially can have an impact. Specific responsibilities include:

- Create and drive implementation of a Rest of World regulatory strategy for assigned products to support lifecycle management of mature products.

- Review and provide scientific and regulatory input on background packages for Agency consultation

- Responsibility for all developmental stages including Clinical Trial Applications (CTA’s) in Phase I-III, Initial Marketing Application filings, and post approval filing activities.

- Provide regulatory review of labeling and will be responsible for the strategy and release of supplementary safety and efficacy supplements to update the label.

- Collaborate with Country Regulatory Leads, Regional Leads, Regional Liaisons, other functional areas within Global Regulatory Affairs across divisions to ensure that a common set of priorities and objectives are developed for ROW filings and lifecycle management activities.

- Lead and drive organizational initiatives and represent Regulatory on cross-functional/cross-divisional teams

- Participate in business process forums

- Mentor team members

- Act as the Global Regulatory Team Lead and Liaison for mature products

Qualifications

Education:

- A Bachelor’s Degree, preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline required with at least 6 years of relevant experience in the pharmaceutical industry.

- Alternatively a Master’s or more advanced degree with at least 4 years of relevant experience in pharmaceutical industry.

Required:

- Prior regulatory experience across a diverse portfolio of products

- Knowledge, exposure and the ability to integrate regulatory knowledge and experiences to strategically

- Critical and logical thinking with the ability to analyze problems, be able to apply creative solutions to complex business and/or technical problems, identify alternative solutions and implement recommendations for resolution within a variety of situations.

- Have led or participated in agency interactions such as FDA, EMA and other major regulatory agency communications, facilitating agency queries and Agency meetings.

- Management of project activities for multiple projects (with possible global exposure/impact), flexibility, and collaborative and negotiating skills are required.

- A thorough knowledge of drug development and global regulatory requirements including the structure and content of regulatory submissions is necessary.

Preferred:

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

- Ability to work effectively both independently and in a team environment, good organizational skills, proven ability to balance diverse activities for multiple projects, general competency, flexibility and negotiating skills are required.

- Strong scientific and analytical skills.

- Experience in working with Clinical Trial Applications

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:

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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:Assoc Prin Scientist, Regulatory Liaison

Primary Location: NA-US-NJ-Rahway

Other Locations: NA-US-PA-Upper Gwynedd

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 1

Shift (if applicable): N/A

Company Trade Name:Merck