Director, Regulatory and Strategic Development (Home Based)
Posted on: June 13, 2019
Clinipace is a global full-service clinical research organization
(CRO) serving the unique needs of venture-backed, mid-tier and
strategic pharmaceutical, biotechnology and medical device firms.
We help our customers advance drug candidates to deliver successful
stakeholder and patient outcomes. We leverage extensive therapeutic
knowledge, clinical trial expertise, and comprehensive innovative
technology to support life science firms in achieving some of their
most important goals: Executing regulatory strategies, optimizing
clinical development timelines and completing high quality trials.
We are proud to have a culture that is vibrant, supportive,
performance-driven, and passionate while focusing on continual
learning and development. Clinipace associates are passionate about
their lives and bring that same passion to their work at
Work Location: United States - Colorado (Boulder) Job Code: 4140
Description Job Title: Director, Regulatory and Strategic
Job Location: Boulder, Colorado or USHome-based
A Director of Regulatory and Strategic Development will be
responsible for the primary delivery of or oversight and management
of allocated projects including regulatory authority licenses,
registrations, exemptions, designations, applications or
authorizations for marketing and sale of a drug product or for the
use of an investigational drug in human subjects. This position
will develop regulatory plans and strategies for emerging and
mid-tier life science client companies. The position will include
client and regulatory authority liaison and requires excellent
technical and verbal and written communication skills. The position
may include the supervision and management of regulatory
professionals and support personnel.
Job Duties and Responsibilities:
- Prepare technical content for and review of regulatory
documentation and submissions.
- Provide regulatory guidance internally to project teams,
functional areas and externally to clients.
- Develop client regulatory plans including timelines, submission
documentation, communication, and reporting and tracking of
- Develop and maintain regional and/or global strategic plans for
the development of client drug product.
- Establish and direct cross-functional teams of internal and
external personnel to deliver client projects.
- Oversight of the compilation and review of regulatory
documentation and submissions ensuring quality, timeliness and
within budget delivery of regulatory tasks.
- Conduct and participate in meetings with regulatory
- Liaise with regulatory authorities, clients, contractors,
consultants and vendors.
- Represent client in regulatory authority meetings, and in
meetings with client partners, investors, collaborators,
consultants and others.
- Oversee timeliness, quality, communication, and within budget
deliverables provided by any contracted regulatory consultants.
- Provide training for internal personnel and supervise staff, as
Supervisory Responsibilities: Directly supervises employees if
required. Carries out supervisory responsibilities in accordance
with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring and training
employees; planning, assigning and directing work; appraising
performance; rewarding and disciplining employees; addressing
complaints and resolving problems.
- ---Bachelors' degree in area of concentration commensurate with
- Post-graduate degree and leadership role in academia or in
pharmaceutical industry highly desirable.
- 10+ years' work experience commensurate with functional area of
responsibility; or combination of work experience, education or
other related industry experience in similar role.
- Experience working in the CRO/ Consulting environment within
- Must have taken different clients to the FDA/ possess exposure
of presenting directly to the FDA on behalf of clients
- Expertise in all stages of regulatory affairs within Clinical
- Marketing operations experience is a must (NDAs, INDs)
- Strong biologics background strongly preferred
- Oral communication: Speaks clearly and persuasively in positive
or negative situations, demonstrates group presentation skills and
conducts productive meetings.
- Safety and security: Observes safety and security procedures
and uses equipment and materials properly.
- Quality management: Looks for ways to improve and promote
quality and demonstrates accuracy and thoroughness.
- Problem solving: Identifies and resolves problems in a timely
manner and gathers and analyzes information skillfully.
- Planning/organizing: Prioritizes and plans work activities,
uses time efficiently and develops realistic action plans.
- Analytical: Synthesizes complex or diverse information.
- Judgment: Displays willingness to make decisions, exhibits
sound and accurate judgment and makes timely decisions.
- Mentor/Teacher: Demonstrates a willingness to organize and
explain complex regulatory or compliance concepts. Has made the
growth and development of others a priority.
- Communicator: Is observed to share information positively,
accurately and effectively with others. Naturally keeps others
informed. Effective communicator both written and verbal to project
team members, cross functionally, to regulatory consultants and to
- Facilitator: Has history of helping diverse groups accomplish
goals in a positive manner. Naturally makes other's job easier.
- Excellent written and verbal communication skills. Excellent
interpersonal skills. Strong computer skills, including Microsoft
The company will not accept unsolicited resumes from third party
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Keywords: Clinipace, Denver , Director, Regulatory and Strategic Development (Home Based), Executive , Boulder, Colorado
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