Director, Regulatory Affairs CMC –Small Molecule Post-Approval Job

Employer
Merck
Location
West Point, PA, US
Posted
August 03 2017
Organization Type
Pharma
Director, Regulatory Affairs CMC –Small Molecule Post-Approval-REG003094

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 Director, GRACS-CMC will provide regulatory leadership, oversight and strategy in support of product/portfolio assignments for products in the post-approval lifecycle. Additionally, the Director will be responsible for leading/directing the "Community Products Team", a group (4-6) of individual contributors supporting the CMC activities for a large portfolio (approx.. 50-75) of approved, low volume products. He/she will be responsible for developing and overseeing implementation of regulatory strategies and making decisions that ensure the high quality of regulatory submissions. He/she will be expected to assess CMC post-approval changes to define regulatory requirements and develop CMC regulatory strategies that demonstrate sound regulatory insight, a balanced approach to risk and knowledge of the changing regulatory environment. He/she will work collaboratively with global stakeholders and peers, to align on priorities and support the achievement of product/portfolio goals.

The Director may also support project team goals and organizational initiatives, on an as needed basis. He/she will be expected to adequately represent the department needs and positions in senior leadership forums. He/she will responsible for proactive and timely communication of challenges and opportunities to management and help address them in a systematic and thoughtful manner. He/she will be expected to embody the Merck values in their day-to-day activities and serve as an example by practicing them on a daily basis. Additionally, the Director will need to have a close working relationship with the CMC Outsourcing lead/team to ensure effective execution of the GRACS sourcing strategy.

Primary responsibilities include, but are not limited to:

Regulatory Responsibilities:

The candidate is expected to drive the application of regulatory strategies and concepts across multiple disciplines and multiple organizations. In addition he/she is expected to develop, execute & provide oversight of regulatory initiatives & strategies of significant complexity and apply exceptional ingenuity to solve problems, confirm acceptability and identification of potential risks and mitigate potential regulatory challenges. He/she will be responsible for assuring timely and accurate compilation and management of all necessary documentation for CMC submissions for license applications, supplements, establishment registrations and regulatory compliance submissions. He/she will work with team members to ensure quality, content and format of regulatory submissions to comply with applicable regulations and guidelines governing the development, licensure and marketing of drugs for his/her products as well as the CPT. The incumbent will provide regulatory oversight for change control impact assessments, discrepancy management, regulatory conformance and inspection management systems. He/she may participate in internal Quality Review Boards, Change Review Boards, Global Regulatory Teams, as needed, to ensure successful communication and alignment between CMC and other GRACS functional areas, any other relevant governance committees and in external regulatory forums. As the lead of the CPT, the candidate is also expected evaluate incoming project requests, ensure alignment with Franchise Management Initiatives and assign work to the CPT as needed. Additionally, the candidate is expected to provide regulatory leadership as needed for product/process outsourcing, product divestment and product withdrawal.

The candidate must maintain a high level of professionalism, efficiency, and follow-through as the leader of their teams. He/she will demonstrate critical thinking, effective problem solving, strong understanding of regulatory strategies, excellent interpersonal skills and the ability to prioritize multiple tasks. He/she must have a proven ability to communicate effectively in both a written and verbal format. He/she must have the ability to work collaboratively in a team structure and must demonstrate a proven ability to work well under pressure. The incumbent will be skilled to lead communications with regulatory agencies to facilitate review and approval of submissions.

Qualifications

Education:

- B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemistry (incl. analytical or organic), Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.

Required:

- At least fifteen (15) years of relevant experience (10 years with an advanced degree) including biological/pharmaceutical research; manufacturing, analytical testing; or related fields.
- The candidate must be proficient in English; additional language skills are a plus.
- Strong experience in regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance)
- Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
- Strong listening skills.
- Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
- Excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts
- Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data is required.
- Depth of experience in defining global CMC strategy and must have collaboration and decision making capabilities
- Demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
- At least 4 years of managing directing a small team of individual contributors or managers of individual contributors
- The candidate may be required to travel on a periodic basis

Preferred:

- Min. of 2 years working with external partners.
- Experience driving change initiative projects
- Experience motivating individuals/teams to manage the change aspects of implementing a new, outsourced model.

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.

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.

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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:Dir, Regulatory Affairs-CMC

Primary Location: NA-US-PA-West Point

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 2

Company Trade Name:Merck