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15 days old

Director, Regulatory Affairs

Kelly Services
Morrisville, NC 27560
Kelly Science & Clinical is seeking a Director Regulatory Affairs who will be an integral member of a growing Regulatory Affairs team. Our client 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.


Please send your resume to Alicia Cali at alic019@kellyservices.com or call/text at 216.256.7768


**Job Overview:** The person hired in this position will be responsible for the preparation 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. The position will ensure maintenance and control of all regulatory submission documentation and assist with developing regulatory plans and strategies for emerging and mid-tier life science client companies. The position will include client and regulatory authority liaison and requires strong 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 regulatory deliverables.

+ Maintain and develop regional and/or global strategic plans for the development of client drug product.

+ Liaise with regulatory authorities, clients, contractors, consultants and vendors.

+ Identify where regulatory specialty expertise is required or regions where local regulatory submission expertise is needed to meet project requirements.

+ Maintain effective internal and client project team communication to ensure quality, timeliness and within budget delivery of regulatory tasks.

+ Participate in internal and client project team meetings.

+ Participate in meetings with regulatory authorities.

+ Provide training for internal personnel and supervise staff, as required.


**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.


**Job Requirements:**


Education


+ Bachelors degree in area of concentration commensurate with responsibility.

+ US add'l: Post-graduate degree and leadership role in academia or in pharmaceutical industry highly desirable.

+ EU add'l: Post-graduate degree (MSc or PhD) and leadership role in academia or in pharmaceutical industry highly desirable.

+ APAC add'l: None


Experience


+ 7+ 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 academic, pharmaceutical, biotechnology or CRO industry preferred.


Skills/Competencies


+ 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.


Capabilities


+ Strong written and verbal communication skills. Strong interpersonal skills. Strong computer skills, including Microsoft Office.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-01-05 Expires: 2022-02-10

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Director, Regulatory Affairs

Kelly Services
Morrisville, NC 27560

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