Executive Director, Regulatory CMC Franchise Lead Job - United States
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 CMC Franchise Executive Director is responsible for the CMC regulatory strategy for all new and marketed products within their assigned portfolio. This lead plays a critical role in driving alignment and execution globally across Regulatory CMC (Chemistry, Manufacturing & Controls), GRACS (Global Regulatory Affairs & Clinical Safety) , MRL (Merck Research Laboratories), MMD (Merck Manufacturing Division) and GHH (Global Human Health) to ensure these programs are compliant and available to patients in markets as needed.
- Leads a team responsible for a group of several related products that include staff supporting pre-approval work and post-approval changes.
- Ensures successful development and implementation of CMC regulatory strategy and plan for the assigned group of projects/products.
- Effectively communicates CMC regulatory strategy, risk, mitigation and overall plan to the GRACS, MRL, MMD, GHH management team, product development teams, and executive management, as relevant.
- Monitors changes in regulatory environment with potential strategic impact working closely with the Head of CMC Regulatory Policy.
- Ensures that all regulatory requirements are met and that systems are used appropriately to ensure proper product control. Ensures appropriate reviews, approvals and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with Health Authorities.
- Performs risk assessments for determination of probability of success for strategic regulatory CMC decisions, approves appropriate level of risk and mitigation for significant issues.
- Proactively identifies and solves the most complex problems with significant impact to the company.
- Develops resource requirements and directs the allocation of the resources to meet profit plan. Works with MRL, MMD, GHH to prioritize work within the assigned group of products to support the profit plan.
- Evaluates key business challenges of products/programs within the franchise and collaborates with team members to direct the development of new and improved solutions.
- Applies appropriate combination of perspectives (business, technical, global, etc.) when making decisions and generating solutions.
- Partners with MMD, GHH, MRL, to ensure robust prioritization of work to meet agreed upon goals across the organization. Influences and drives development of innovative solutions to problems and ability to make rapid, disciplined decisions across divisions.
- Ensures development of staff with either pre or post-approval experience to train across modalities to position them for opportunities in either modality.
- Represents CMC modality(ies) on key executive level meetings. Actively engages as an LT member within the primary modality.
- Establishes strong cross-functional and divisional relationships with key stakeholders, customers and external organizations.
- Bachelor’s Degree with a minimum of (20) years’ experience in the Pharmaceutical Industry
- Preferred: Advanced degree (PhD preferred) with a minimum of (15) years’ experience in the Pharmaceutical Industry
- Minimum of (10) years experience in Regulatory CMC with progressive experience in leading global programs from pre-approval through post-marketing.
- Minimum of (7) years People Management / Leadership experience with proven track record of developing talent.
- Demonstrated ability to anticipate and influence within and across divisions/business units and in the external business and regulatory environment to identify potential challenges impacting the business and proactively recommend approaches to minimize regulatory risk
- Recognized as a leader both internally and externally with broad expertise in CMC regulatory strategy and dossier management activities across product development, registration and life-cycle management. Present and influence key topics at Industry/Agency meetings and conferences.
- Demonstrated ability to recruit, train and develop staff, to motivate others and drive continuous improvement.
- Flexibility to operate in a matrix-managed environment and to support staff in that same environment.
- 10% Travel
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 firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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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 - CMC
Job Title:Exec. Dir, Regulatory Affairs-CMC
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Manager, Regulatory Affairs, Law, Franchise, Legal, Management, Retail