Regulatory Affairs Manager/ Senior Executive

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JOB BACKGROUND:

Atnahs is a fast-growing pharmaceutical company with a portfolio of over 15 brands across 130 markets. Our team of over 90 employees are based across our offices in Basildon (UK), Copenhagen (Denmark) and Vadodara (India).

We acquire, develop and market a portfolio of mature branded medicines globally:

Acquire

We acquire “mature” (i.e. post-patent expiry), established branded prescription medicines from large cap and speciality pharma.

Develop

We develop line extensions (new formulations or new markets) to the medicines we acquire. We also develop our own niche generic medicines in-house.

Market

We currently own and market a portfolio of more than 18 medicines and operate in more than 130 markets globally.

Our regulatory department is responsible for providing regulatory strategic advice and life cycle maintenance for the portfolio, globally. In addition, support with new product development initiatives

We seek highly motivated individuals, with strategic thinking to join our growing team

MAIN RESPONSIBILITIES & DUTIES:

  • Provides strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.
  • Leads the preparation of core dossiers and submissions for global roll out.
  • Authors, reviews and approves M3 dossier sections as necessary, justification documents and Product Information.
  • In collaboration with global partners, consultancies and distributors, outlines global regulatory intelligence and form a global regulatory strategy.
  • In collaboration with senior management and project strategy teams, develops and reviews global cross functional regulatory strategies.
  • Ensure diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meeting
  • Negotiates and makes agreements on behalf of the department.
  • Interprets applicable regulations and guidelines for project team use. Keeps project team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans.
  • Serves as a primary contact to the local health authority (HA(s), local consultancies/ distributors and internal stakeholders, to ensure timely and accurate submissions.
  • Facilitates communication between the HA(s) and the project team. Attends and generally leads agency meetings, if required.
  • Coordinates and solicits components of the submission from various functional areas, distributors and CMOs.
  • Proactively identifies project issues to the project team and supports mitigation plans.
  • Attends cross functional meetings, vendor meetings and kick-off meetings as required.
  • Mentors and/or manages other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff.
  • Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses.
  • Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and overseeing regulatory submissions.

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