Director of Regulatory Affairs

Director of Regulatory Affairs

Job Description

This position will lead the regulatory strategy for all the products in the pipeline. She/he will be responsible of multiple innovative global regulatory strategies for product development and approval. Responsible for defining strategies, for regulatory documents, submissions, and compliance issues. Represent the company with all international regulatory authorities, reporting to the Chief Executive Officer, the Director of Regulatory affairs is a critical role intended to lead and coordinate the regulatory strategy of the company.

Responsibilities

  • Lead, develop and implement regulatory strategy in order to meet corporate goals and objectives
  • Responsible for preparation/submission/maintenance IND/IMPD and future MAA and BLA
  • Lead and participate in the planning, preparation and delivery of submissions throughout the product’s life cycle including briefing documents, INDs, CTAs and annual reports
  • Lead and plan scientific advice meetings with regulatory authorities for all of the pipeline products
  • Lead Preparation and submission of Orphan Drug designation requests
  • Lead the planning, strategy, content and execution of future MAA filing and approval
  • Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risk
  • Provide regulatory oversight and guidance to project teams on compliance matters, FDA, EMA and other competent authority requirements, clinical study design issues and on timing, logistics and operational recommendations for product development
  • Prepare the team and lead negotiations with FDA, EMA and other health agencies
  • Provide regulatory due diligence as required
  • Advise CMC, Clinical and non-clinical functions (Process Development, Analytical Development, Manufacturing and Quality Control) on the preparation and content of IMPDs, INDs, BLA and MAA dossiers to ensure timely delivery of final documents to be included in submissions
  • Guide CMC stakeholders and project management on regulatory issues and impact assessment including CCRs and Deviations with the QA Team and maintain records of the decisions
  • Responsible for the development and implementation of the Regulatory Compliance system and for developing the relevant procedures
  • Oversight of up-to-date electronic database of documentation (e.g. up-to-date eCTD sections, IMPDs)
  • Maintain an up-to-date knowledge of the relevant (EU, US and ICH) regulations, pharmacopoeias, guidelines and gain regulatory intelligence by visiting relevant meetings and conferences
  • Represent the Company at meetings with Regulatory Authorities
  • Follow new regulatory requirements including analyzing new and emerging requirements and assessing their impact on the development pipeline
  • Providing counsel, training, and interpretation of FDA, EMA and other regulatory issues to Company personnel and assisting as a liaison between the Company and Regulatory Authorities.

Qualifications

  • 8-10+ years of Regulatory Affairs or related experience, Master or a higher scientific degree (MD, PharmD, PhD)
  • 8-10+ years experience in therapeutic products (preferably biologics and advanced therapeutics)
  • 8-10+ regulatory experience in the biotech/pharmaceutical industry in the pre-market setting
  • Previous documented participation in preparing Regulatory submissions (IND, CTA, BLA, MAA etc.) to the FDA and EU Regulatory Authorities
  • Experienced in Regulatory Agency meetings resulting in successful outcomes
  • Experience with global regulatory submissions and an understanding of worldwide drug and biologics guidelines and regulations
  • Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP, ICH Guidelines for CTD/eCTD, EMA and CDER requirements for the drug approval process
  • Solid understanding of the e-CTD specifications for electronic submissions.
  • MS Office Expertise: Outlook, Word, Excel, PowerPoint, Project, Visio
  • Creative problem solver, analytical thinker, and quick learner; ability to work through ambiguity; quick study of new or complex concepts; relentlessly resourceful and diligent
  • Excellent leadership skills with ability to gain trust and support from investors and management
  • Excellent presentation and communication with C-level executives
  • Fluent in English
  • Previous Experience with PRIME application is a big plus.

For more information please write to info@entherapharmaceuticals.com.

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