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Regulatory Affairs Manager

Lonza

Basel or Visp, Switzerland

Job Description

  • Prepare and support DMFs and NDA/MAA/BLA for customers (for small molecules, peptides, ADCs and/or microbial biotech products);
  • Support site specific regulatory documents;
  • Provide regulatory support and advice for internal and external customers in line with defined;
  • Regulatory plans and in response to ad-hoc questions;
  • Maintain documented regulatory project plans in line with best practice recommendations;
  • Update functional leads and maintain transparency of information across regulatory function;
  • Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the LPB RA team.

(Reporting to Head of RA LPB Basel)

Responsibilities

  • Prepare and support DMFs and product licence applications for customers;
  • Provide strategic and operational regulatory direction for projects under responsibility;
  • Lead and implement all submission activities (planning, review, coordination, submission) for new document creation and document updates;
  • Support country-specific regulatory documents;
  • Support assessment of change requests;
  • Oversee preparation of answers to Health Authority Questions or customer requests on regulatory documents;
  • Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions;
  • Establish and maintain sound working relationships with internal and external customers;
  • Maintain documented regulatory project plans in line with best practice recommendations;
  • Update functional leads and maintain transparency of information across regulatory function;
  • Support site specific regulatory documents;
  • Interact with internal departments to improve facility processes and systems and provide regulatory impact of proposed improvements;
  • Evaluate process and system improvements for potential regulatory impact.

Provide regulatory advice to functional areas on site

  • Regulatory developments & new guidelines;
  • Interpretation of Health Authority regulatory requirements;
  • Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the LCM-C RA team;
  • Support the implementation of change control activities within the Global Regulatory LCM-C team, as appropriate;
  • Projects under responsibility include development and marketed drug substances (synthetic or semi-synthetic small molecules, biologics or antibody-drug conjugates) for human or veterinary use.

Education

Masters: Biochemistry, Masters: Biology, Masters: Chemistry.

Work Experience

Quality, Regulatory.

Experience Level

Intermediate.

Certifications

Skills

At least 2-4 years of related pharmaceutical industry experience in regulatory affairs, CMC Regulatory Affairs, Competent in Microsoft Office Software (Word, Demonstrated ability to manage priorities and work under tight timelines, Experience of preparing and authoring module 3 CTD, e.g. for IND/IMPD and NDA/MAA/BLA, Superb organisational skills and attention to detail.

Language(s)

English, French, German

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