The Global Regulatory Liaison is responsible for development and
implementation of worldwide regulatory strategy for their assigned
projects in the Oncology, Immunology and Devices therapeutic area.
The candidate will be a self-starter and provide regulatory
oversight for assigned products, in order to optimize label and
obtain shortest time to approval by regulatory agencies.
Independently manages projects, functioning as the single,
accountable, global point of contact on those projects.
Independently interacts with the Worldwide Regulatory Agencies
and/or subsidiaries with regard to global regulatory
strategy/registration requirements for one or more of our Company's
investigational and marketed drugs/biologics. Programs may be
complex with more than one indication, formulation or have an
external business partner. Coordinates the preparation, submission
and follow-up contact with regulatory agencies and/or subsidiaries
for all applications and submissions. Responsible for regulatory
review and final approval for all submissions and associated
documentation. Provides expertise as worldwide regulatory
Product Development Teams and regulatory single point-of-contact
for products within Global Regulatory Affairs and Clinical Safety
(GRACS) and external to GRACS. Primary activities include, but are
not limited to:
Develops worldwide product regulatory strategy to optimize label
and obtain shortest time to approval by regulatory agencies for
multiple indications simultaneously.
Provide expert advice to Product Development Teams and
subsidiaries on regulatory issues as they arise with the
developmental compounds or marketed products throughout the entire
life cycle of the drug.
Provide direction to the staff by leading the Global Regulatory
Team which coordinates cross-functional regulatory support for
development programs and marketed products.
Review and provide final approval of local registration study
protocols when needed to obtain marketing authorization in
Represents our Company with external organizations through
direct communication with the FDA, including telephone calls and
e-mail; chair meetings between company and FDA; prepare our
Company's teams for meetings with FDA at any phase of drug
Lead cross-functional efforts to prepare for advisory
Coordinate interactions with foreign agencies through Regulatory
Affairs Europe (RAE) and the subsidiary registration departments to
support their interactions and provide strategic direction across
multiple regions simultaneously.
Review and provide final approval of Worldwide Marketing
Applications, Clinical Study Reports, protocols, and Investigator
Brochures before release from our Company to external
Represent GRA within our Company's internal committees to
provide regulatory advice and approval according to the committee
charters (therapeutic area Document Review Committees (DRC),
Product Development Team (PDT), Early Development Team (EDT), and
labeling teams (LEAD).
Conducts initial IND/CSA content review and approval to
facilitate initial approval by agencies for conduct of clinical
- Participate in regulatory due diligence activities for
licensing candidate review.
Education Minimum Requirements:
B.S. Degree in biological science, chemistry or related
discipline, with minimum of 10 years drug development or clinical
experience or regulatory affairs.
M.S. with minimum of 10 years drug development or clinical
experience or regulatory affairs.
PhD with minimum of 7 years relevant experience.
- M.D. with minimum of 5 years relevant experience
Required Experience and Skills:
Ability to achieve optimal results with limited day-to-day
Ability to think strategically and continuously learn and apply
Ability to lead, influence, and negotiate.
Led or directly supported meetings with FDA, EMA, or other
Led or directly supported regulatory filings.
- Proactive, clear and effective verbal and written
Preferred Experience and Skills:
We are a research-driven biopharmaceutical company. Our mission
is built on the simple premise that if we "follow the science" that
great medicines can make a significant impact to our world. We
believe that a research-driven enterprise dedicated to world-class
science can succeed by inventing medicine and vaccine innovations
that make a difference for patients across the globe.
Who we are
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA
in the United States and Canada and MSD everywhere else. For more
than a century, we have been inventing for life, bringing forward
medicines and vaccines for many of the world's most challenging
diseases. Today, our company continues to be at the forefront of
research to deliver innovative health solutions and advance the
prevention and treatment of diseases that threaten people and
animals around the world.
What we look for
In a world of rapid innovation, we seek brave Inventors who want
to make an Impact in all aspects of our business, enabling
breakthroughs that will affect generations to come. We encourage
you to bring your disruptive thinking, collaborative spirit and
diverse perspective to our organization. Together we will continue
Inventing For Life, Impacting Lives while Inspiring Your Career
Invent. Impact. Inspire.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee
Placement, all employees subject to this policy are required to
have a minimum of twelve (12) months of service in current position
prior to applying for open positions.
If you have been offered a separation benefits package, but have
not yet reached your separation date and are offered a position
within the salary and geographical parameters as set forth in the
Summary Plan Description (SPD) of your separation package, then you
are no longer eligible for your separation benefits package. To
discuss in more detail, please contact your HRBP or Talent
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates
can engage in a hiring process that exhibits their true
capabilities. Please click here if you need an accommodation during
the application or hiring process.
For more information about personal rights under Equal
Employment Opportunity, visit:
EEOC GINA Supplement
OFCCP EEO Supplement
We are proud to be a company that embraces the value of bringing
diverse, talented, and committed people together. The fastest way
to breakthrough innovation is when diverse ideas come together in
an inclusive environment. We encourage our colleagues to
respectfully challenge one another's thinking and approach problems
collectively. We are an equal opportunity employer, committed to
fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck
Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept
unsolicited assistance from search firms for employment
opportunities. All CVs / resumes submitted by search firms to any
employee at our company without a valid written search agreement in
place for this position will be deemed the sole property of our
company. No fee will be paid in the event a candidate is hired by
our company as a result of an agency referral where no pre-existing
agreement is in place. Where agency agreements are in place,
introductions are position specific. Please, no phone calls or
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings: