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Regulatory Affairs Lead

Posted on Jan 30, 2020 by Harvey Nash IT Recruitment Switzerland

Opfikon, Zürich, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

For our client in Opfikon (Zurich) we are looking for Regulatory Affairs Lead for a 8 months project

Description:

Job/Position: Regulatory Affairs Lead
Location: Opfikon (Zurich)

Duration: 24/02/2020 - 23/10/2020

Workload: 100%

ROLE OBJECTIVE

  • Leading the local Swiss overall regulatory strategy working in collaboration with the Regional and Global Regulatory Leads to successfully deliver the product development and life cycle management plans in accordance with agreed business priorities. Also responsible for ensuring the compliance of registered products with local laws and requirements
  • Serving as the key liaison between the company and the local Health Authority and also the Industry Associations. Building strong working relationships and conduct yourself with integrity with both internal and external stakeholders
  • Leading a highly effective team who strives for a performance-based culture and deliver operational excellence working in a cross-functional environment within R&D and the Commercial business. As a team leader, coaching and facilitating the professional development of the team will be a high priority

ACCOUNTABILITIES

  • Accountable for local Regulatory Affairs (RA) input into submission and launch strategy, aligned with commercial plan, and for timely submission & approval of marketing authorisation applications, variations and renewals. Maintain relevant knowledge of company's pipeline
  • Ensure RA support for local product launches and early access programs. Collaborate with Market Access and Health Economics teams on the evidence generation and value proposition strategy including preparation of the Pricing and Reimbursement Dossier (HTA)
  • MA life cycle maintenance incl. renewals, variations (CMC and non-CMC), labeling updates, PSUR/PBRERs etc. Ensure national registrations are aligned with global dossier updates. Provide relevant local impact assessments for global dossier changes
  • Due diligence for locally in-licensed products from RA perspective including support for MA Transfers
  • Manage compliance of labelling (and mock-ups) with CCDS (incl. updates for generics if originator product changes). Local translations of SmPC, labelling, patient information and
    distribution to internal and external stakeholders (incl. public lists, websites). Ensure permanent inspection-readiness of RA function
  • Be the primary contact for regulatory health authorities (HA) in national procedures and post-approval. Build relationships with HA, understand their internal workings, maintain open communication channels and respond with urgency and accuracy to Health Authority requests. Active involvement and participation at Industry Associations where possible
  • Ensure conformity of products with EU and local laws
  • Maintain Global and Local Regulatory databases to ensure accurate records of Regulatory activity
  • Contribute to Regulatory Intelligence, monitor local regulations and assess the impact on local business and products
  • Ensure regulatory review of promotional materials

TEAM LEADERSHIP

  • Provide leadership to a team of RA professionals located within the LOC. Accountable for goal setting, performance & workload monitoring, resourcing, staff hiring, training, and budget planning
  • Assign product responsibilities in the team, manage RA contractors/CROs and ensure oversight of outsourced RA activity
  • Committed to Personnel Development
  • Ensure alignment of RA Team focus with global R&D strategies and LOC business priorities
  • Support continuous improvement and process simplification in collaboration with EU RA leadership and local partners
  • Ensure regular and ad hoc presentation of RA topics to the LOC country leadership team and help ensure "One R&D voice" is delivered in the LOC. Represent the country at European/Global RA level

SKILLS and LEADERSHIP CAPABILITIES

Critical Skills and Competencies

  • Knowledge of the national and EU pharmaceutical legislation
  • Understanding of Drug Development and Marketing processes and requirements
  • Strong scientific background
  • Proven interpersonal, communication, analytical, and organizational skills
  • Ability to challenge self and others to overcome barriers and deliver high quality solutions
  • Able to drive alignment between functional and commercial objectives
  • Strong negotiation skills and project management competencies
  • Mature professional presence & credibility
  • Ability to work under pressure

Experience and Education

  • Higher degree in related scientific disciplines (pharmacy, biochemistry, biology)
  • Minimum 8 years of experience in Pharmaceutical Regulatory Affairs, including QA/QP (FvP) and PV experience
  • Expert in RA with deep QA and PV knowledge
  • In depth knowledge of applicable laws, regulations and codices for pharmaceutical industry
  • Fluent written & spoken German, French & English/Italian as additional national language is a plus

For further details please contact Aleksandra Kalicka:

e-mail: (see below)


Reference: 835116686

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