Director, Regulatory Affairs International Job

Director, Regulatory Affairs International-REG002785

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) Therapeutic Area Leader (TAL), reporting to the Executive Director RAI-HQ, leads a group of RAI HQ Liaisons who are responsible for the development and implementation of regulatory strategies for Rest of the World (ROW) countries and for particular projects in their assigned portfolio. The portfolio may include products in all phases of development through registration and mature products. For new programs, the TAL will provide guidance to RAI HQ Liaisons on global regulatory development and filing strategy, especially for ROW countries. For mature products the TAL will have responsibility for overseeing global product regulatory strategy and issues related to maintaining these products on the market.

The individual functions with a high degree of independence and provides oversight and direct management of RAI HQ liaisons in their therapeutic area. They provide technical and professional leadership to staff handling multiple projects. Drug development and regulatory expertise is leveraged to provide guidance and manage RAI HQ Liaisons.

Specific responsibilities include:

- Manage individuals that create and implement ROW regulatory strategy for assigned products to optimize time to approval.

- Manage individuals that create and implement regulatory strategy to support lifecycle management of mature products.

- Oversight, management, and review of Liaisons including review of regulatory strategy for Liaison’s.

- respective products as needed.

- Review and provide final approval for background packages for Agency consultation to ensure clarity and comprehensive presentation of issues.

- Provide review of labeling

- Collaborate 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 that a common set of priorities and objectives are developed for ROW filings and 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 such as managing performance, development planning; staffing and related people-management responsibilities for liaisons within areas of responsibility.

- Lead organizational initiatives on behalf of the RAI HQ Leadership Team and represent RAI HQ on cross-functional/cross-divisional teams.

- Mentor team members and provide guidance on various aspects of Regulatory Affairs and their projects.

- Develop team members and their capacity to manage or resolve difficult regulatory issues independently.

- Coach team members to develop annually an Employee Development Plan and Personal Performance Grid.

Qualifications

Education:

- Degree in Pharmacy, Biological Science, Chemistry, Nursing, Medicine or related discipline.

Requirements:

- Bachelor’s degree, preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline required with at least 12 years of relevant experience in the pharmaceutical industry. Alternatively a Master’s degree with at least 10 years of relevant experience in pharmaceutical industry or Doctoral level Degree (e.g. Ph.D, M.D.) with 5 years of regulatory affairs and clinical drug/biologic development experience.

Required:

- The RAI-HQ Liaison must have demonstrated, via their current role, the ability to think strategically and execute complicated strategies as well as exceptional leadership skills.

- They must demonstrate good 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.

- Additionally, they must be viewed as a Subject Matter Expert (SME) in their current field of work.

- They must have excellent communication (both oral and written) and organizational skills, as well as the ability to effectively and successfully lead a team.

- Management of team 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.

- 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.

- 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.

- Preferred Experience and Skills:

- Prior people management experience is preferred.

- Prior regulatory experience across a diverse portfolio of products is preferred.

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:Dir, 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

Shift (if applicable): 1st

Hazardous Materials: None

Company Trade Name:Merck