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Regulatory Consultant- Life Science/ pharma consulting

2 months ago


Edison, United States Diverse Lynx Full time


Job Title
Regulatory Consultant

Location
Edison, NJ

Candidate for this position to be offered with TAIC or TCSL as Entity

Talented transformational consultants who can demonstrate operational experience and digital /IT Transformation experience

A track record of successful involvement in digital transformation or improvement in Life Sciences Regulatory Affairs domain

Excellent written and verbal communication and presentation skills to operate effectively at all levels of the business.

Willingness to work away from the home base at a client s site, the ability to work remotely and to be self–sufficient and resourceful as necessary.

5. An articulate, confident and engaging individual with strong people skills who can facilitate client groups

6. Familiar with usual office software plus selected or dedicated (as per focus area above) relevant domain specific packages.

A commercial fluency in a second language would be useful particularly French/German

8. A good understanding of the changing regulation in the industry currently and their impact on the Pharma or Medical Device companies

Relevant Experience

(in Yrs)
8 to 14 years of experience in Regulatory Affairs or Regulatory Intelligence. At least 4 years in Regulatory Intelligence/ CMC or Labeling. Consulting or IT Transformaton experience is essential.

Must Have Technical/Functional Skills

Assertive,

Situational Leadership,

Process Mapping Competency

RAPS (or equivalent) Certification

1 2 years of business development and client relationship management desirables

Experience in 2–3 additional LS specific domain areas would be desirable

Roles & Responsibilities

Plan and Execute Regulatory Transformation project with excellent presentation skills, ability to manage situations and team structure incl. client.

Development of consulting and advisory related too

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.