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Drug-Device CMC Regulatory affairs manager

Requested experience: minimum experience of 4 years in technical regulatory affairs

Location: Villeneuve d’Ascq (59) – France

Job type: Full-time position – On-site

Gross salary: 56-70 k€ Bonus included – depending on professional experience

Company

Hemerion Therapeutics is a health tech company at a clinical level. Hemerion results of over 10 years of leading academic and clinical research on innovative approaches to treat Glioblastoma. Hemerion owns a unique and disruptive technology, already evaluated in frontline approach to treat patients harboring brain cancer.

Description

We are seeking for our future CMC Regulatory Affairs Manager who will supervise and strategize the regulatory development of our Drug and Device combination product utilized in the management of newly diagnosed glioblastoma.

Location

Primary location: Hemerion Therapeutics 37 rue Denis Papin 59650 Villeneuve d’Ascq Position may require foreign travels (EU and USA)

Responsibilities

Under the supervision of the CEO, you will manage the regulatory affairs team. By the mean of collaborations with partners and consultants, your missions are the following:

  • To oversee and develop all pre-market regulatory strategies regarding the product development to accelerate the approval of our new therapeutic approach
  • To be accountable for author, review and approval of CMC submissions and responses to Health Authority (FDA, EMA, ANSM and other national health agencies) questions in line with agreed regulatory strategy, and within agreed timelines (IND, IMPD)
  • To Lead cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions for assigned projects/products
  • To partner with R&D and clinical affairs leads for exchange of project/product related information and submission planning
  • To partner with our CMC and CDMO suppliers to ensure our drug product related information and submission planning
  • To be accountable for the coordination and overall global approval of regulatory assessments for CMC changes
  • To monitor and influence changes in the global regulatory CMC environment in alignment with business needs
  • To define and communicate the need for external regulatory CMC resource to the management team as required to deliver CMC submissions for assigned projects/products in all regions to the agreed timelines
  • To manage and follow-up of the different pre-submission meetings with the health agencies
  • To maintain awareness of relevant global regulatory legislation and assess the impact of new technical standards and regulations and participate in the implementation of actions
  • To contribute to the design of upcoming clinical trials and define the best endpoints to support the drug development
  • To contribute to our quality management system

Qualifications

  • Pharmaceutical or scientific university degree (MSc, PhD) in Life sciences, Chemistry, Biology or Pharmacist (PharmD)
  • Knowledge of, and practice of ICH guidelines, GMP
  • Knowledge of, and practice of regulatory procedures (FDA / EMA / ANSM)

Experience/Profile

Minimum experience of 4 years in technical regulatory affairs (CMC writer of Quality sections of IDE/IND/IMPD/NDA/CTDs).

Skills

  • Good understanding of clinical trials during premarket approval
  • Fluent in English and French for daily contacts with local and international partners
  • Excellent organizational and interpersonal skills
  • Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones
  • Intermediate to advanced Microsoft Office skills (Word, Excel, PowerPoint and Outlook)
  • Excellent verbal and written communication
  • Organized and able to meet deadlines

PERFORMANCE GOALS

Ensure authoring, reviewing and submission of regulatory dossiers are running according to agreed regulatory strategy, and within agreed timelines.

Job benefits

  • Dynamic environment with opportunities for advancement within the company
  • International and growing company
  • Autonomy in building the job’s functions
  • Eligible to incentives such as BSPCE warrants

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