SR. DIRECTOR, REGULATORY AFFAIRS STRATEGY
Company: Sun Pharmaceutical Industries, Inc.
Location: Cranbury
Posted on: October 9, 2024
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Job Description:
Senior Director, Global Regulatory Affairs Strategy The position
will provide regulatory affairs strategic leadership for the
company and novel drug development programs. Of each program this
position supports, the individual will be responsible for
developing and executing the overall regulatory strategy, which
includes developing the registration pathway, interacting with
regulatory agencies, and being responsible for all associated
regulatory filings. ResponsibilitiesDevelop and execute novel drug
regulatory strategyEnsure development programs are compliant with
ICH regulatory requirements and all local country regulatory
requirementsStrong project management skills and strong
interpersonal skills to handle complex distributed programsAbility
to author clear and concise regulatory documents with oversight of
all documents for regulatory submissions and associated
messagingWork closely with regulatory CMC lead and overall
development team to insure overall regulatory strategy and
regulatory CMC strategy are alignedBe the point of contact between
the company and the regulatory agency - serve as the regulatory
liaison for the company QualificationsMaster's degree in Chemistry,
Biochemistry, Pharmacy, Biomedical Engineering, or Chemical
Engineering is mandatory; PhD or PharmD in above disciplines are
preferred10+ years industry experience a must with RA novel drug
developmentCMC and/or Botanical experience, RAC
certificationThorough understanding of ICH and US CFR requirements
and regulations.Regulatory document submissions authoring
experience (INDs, IMPDs, NDAs, BLAs, briefing books)Regulatory
agency direct interaction experienceStrong communications
skills
Keywords: Sun Pharmaceutical Industries, Inc., Fairfield , SR. DIRECTOR, REGULATORY AFFAIRS STRATEGY, Executive , Cranbury, Connecticut
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