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

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


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

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 may also manage a small number
of individual contributors who are responsible for their own portfolio of
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.

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 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. 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 and any other relevant governance
committees and in external regulatory forums.

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.



The candidate should possess an advanced degree in science (PhD preferred) with at least 15 years or more of experience in pharmaceutical industry (10 years with an advanced degree).

The ideal candidate will have:

- 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).
- The candidate must demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
- 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.
- He/she must have a depth of experience in defining global CMC strategy and must have collaboration and decision making capabilities to be successful in this role.
- The candidate must have excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts. The candidate must be proficient in English; additional language skills are a plus. The candidate may be required to travel on a periodic basis.
- The candidate is expected to develop and possess an expert knowledge of Industry Association Whitepapers, HA regulations & guidance documents. He/she is expected to utilize the expert knowledge and reputation to influence the content of new Industry Association Whitepapers, HA guidance & regulations.

- A candidate with experience in CMC post-approval lifecycle management and strong API expertise is preferred

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

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 - 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: 1

Company Trade Name:Merck

Similar jobs

Similar jobs