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Job Details

Regulatory Programme Manager

Company: Roche
Location: Welwyn
Reference: 201807-115787
Closing Date: 10 Jan 19
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Regulatory Programme Manager Please note: This is a Roche Welwyn (UK) only position.  No other Roche or Genentech Global sites are available.Key Responsibilities Represents and/or supports the Regulatory Leader in representing the function on cross-functional teams Local and Global teams and Established Product Teams (EPT).Manages the registration procedures in EU (Centralised, Decentralised or Mutual Recognition). ...

Requirements:

Regulatory Programme Manager

Please note: This is a Roche Welwyn (UK) only position.  No other Roche or Genentech Global sites are available.

Key Responsibilities

  • Represents and/or supports the Regulatory Leader in representing the function on cross-functional teams Local and Global teams and Established Product Teams (EPT).
  • Manages the registration procedures in EU (Centralised, Decentralised or Mutual Recognition).  
  • Prepares EU regulatory submissions in collaboration with the other disciplines.
  • Gives specific guidance to respective teams on EU regulatory legislation, guidelines, procedures.
  • Takes the lead in the interaction with regulatory agencies and drives responses to questions from authorities and subsidiaries.
  • Responsible for regulatory management of countries, in collaboration with local affiliates and/or regulatory regional management.
  • Analyzes regulatory environment for impact on product(s)/plans and briefs Established Product Team(s)/ Regulatory Affairs Functions Team (RAFT)/management as appropriate.
  • Gives strategic input at RAFT and EPT level. Coordinates activities with RAFT resources to ensure that tasks are completed within defined due dates and meet regulatory and departmental processes.
  • Ensures regulatory strategic options, assessments and risks are communicated to product teams with Global Team Leader as appropriate.
  • Interfaces with external partners/vendor companies as appropriate for regulatory submission/approval procedures including license renewals.
  • Is responsible for local regulatory strategy for EP being considered in the global strategy.
  • Is responsible as primary interface to Affiliate Drug Regulatory Affairs in scope for communicating regulatory information in a timely manner, enabling dialogue and their contribution in all relevant Established Products activities.  
  • Provides regulatory recommendations concerning acceptable labelling in regional markets, in collaboration with relevant functions.


Core Competencies

Leadership:
  • Provides strategic input, sets milestones, allocates responsibility and monitor progress towards results.
  • Takes responsibility to resolve issues objectively.
  • Ensures appropriate identification and escalation of issues or potential critical issues as needed.
  • Works with cross-functional teams, RAFT and external vendor companies to achieve company goals/objectives.

Strategic and Creative Thinking:
  • Apply regulatory and scientific knowledge to determine solutions and solve complex problems. 
  • Develop clear, effective and creative regulatory strategies to support business needs.

Communication and Negotiation:
  • Influence individuals or groups at more than one level who may have different interests or goals to reach consensus and achieve team objectives.
  • Fosters good interpersonal relationships.
  • Builds trust and respect with peers and team members including external partners and vendors.

Teamwork:
  • Work effectively to share responsibility as a team member.

Technical Competence:
  • Possess working knowledge of scientific and regulatory environment.
  • Analyze and understand current and historical regulatory environment and its impact on assigned products.

Minimum Qualifications and Experience
  • Preferably university degree in a scientific/technical discipline.
  • Knowledge and experience of EU or major country regulatory processes (e.g successful management of Centralised/Mutual Recognition Procedure in the EU).
  • Practical experience of successfully managing Health Authority interactions in Europe (EMEA/ CHMP and National Authorities) or major countries.
  • Knowledge of development, manufacturing and marketing.
  • Demonstrates core competencies.
  • Commitment to performance measures of time, costs and quality.
  • Fluency in spoken and written English.

Closing date for applications is Wednesday 19th December 2018.

Roche is an equal opportunity employer.
Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

Apply for this job: Regulatory Programme Manager

Contact Information:

Address:  UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
AL7 3AY
England
Tel:  +44 1707 36 6000
Fax:  +44 1707 33 8297
Website:  Visit Our Web Site

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