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Job Details

EMEA RMC Professional /- Regulatory Affairs / RA - Pharmaceuticals

Company: Elevate Direct Ltd
Location: Leiden, Netherlands
Reference: PH-AL-RMCJJ-080817
Closing Date: 08 Sep 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

EMEA RMC Professional / Leiden, Netherlands / 5 Months Contract / 80 to 156 EUR (Per Hour)

Requirements:

EMEA RMC Professional - Regulatory Affairs

 Leiden, Netherlands / 5 Months Contract / 80 to 156 EUR (Per Hour)

The Regulatory Management Center is a new regional organization to handle the majority of LOC (Local Operating Company) activities led by senior regional regulatory staff, where they will handle tactical LCM processes (CMC Variations and Labeling Changes) in the region. The Center will be embedded in the AP, EMEA and LA regional organizations, and it will work in close collaboration with the respective LOCs and regional and global departments.

The RMC is a virtual, dedicated team consisting of GRA regional team members (direct reports) and LOC team members (matrix organization).

The responsibility of RMC Professionals is to lead wide range submission processes for multiple countries, preparing country-specific submission ready dossiers,manage Agency questions when required and ensure post-approval activities to take place for those submissions.

Principle Responsibilities

  • Lead and facilitate LOC CMC variation / label change processes from global dispatch to kick-off of local implementation following RMC processes
  • Prepare submission plan based on global dispatch and country specifics
  • Prepare submission-ready dossier based on local regulations and country specific requirements covered in “recipe book” – in collaboration with LOC staff
  • Assess and implement label changes
  • Involve specialists for specific process steps, eg. for ePackmat

Required Technical Competencies & Knowledge

Regulatory Strategy

  • Good understanding of the pharmaceutical industry and regulatory experience in drug development and/or marketed products.
  • Detailed knowledge of local regulations and guidances in the /cluster/region related to full drug life cycle. Understanding of how these apply to specific projects and how to interpret them in the context of the scientific and commercial environment.
  • Awareness of the scientific principles (CMC, clinical and non-clinical) applicable to the specific products.
  • Knowledge of quality and supply chain and potential impact to regulatory procedures and status of products
  • Drive execution
  • Project management: get things done, drive execution, collaborate in virtual teams, task prioritisation
  • Communication skills and cultural sensitivity in working with stakeholders across countries
  • Able to communicate in English and have general understanding (incl technical RA English)
  • Team player able to effectively collaborate with colleagues in virtual environment and able to do efficient handovers

Submissions

  • Ability to quickly acquire local knowledge and shift between local situations (learning agility)
  • Solid RA submission process knowledge; Able to interpret guidances as they apply to submissions in the countries in scope.
  • Knowledge of what is needed for dossier components and submissions, how to obtain regional components and understanding of timelines. Understanding of documentation requirements.
  • Ability to determine whether documents meet regulatory requirements, and are consistent with the regulatory strategy.

DECISION-MAKING AND PROBLEM-SOLVING:

  • Operates in a competitive, complex, and rapidly changing environment.
  • Independence on decision-making regarding regional strategies with supervisor approval.
  • Identify and act on process optimization opportunities
  • Defines operational priorities and tactics.
  • Resolves conflicts in priorities in consultation with supervisor,
  • Makes informed decisions by soliciting input from others where needed.
  • Decisions and problem-solving require interpretation of applicable country-specific and company procedures, policies, standards, and regulations in drug regulation , but will not be explicitly circumscribed by these.

Independence/Autonomy:

  • Operates independently in a complex environment within given boundaries. Independent in daily activities, with limited managerial oversight.

KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:

  • A minimum of a University degree or equivalent by experience
  • 5+ years of submission handling experience
  • Experience of working in a virtual team and/or global organization would be an asset .
  • Previous experience in RA role as Associate, Professional or similar role is of advantage.
  • In depth knowledge of local and regional regulations/legislation.
  • Experience in working with limited supervision and able to make independent decisions
  • Excellent verbal and written communication skills – proficiency in written and oral English
  • Cultural sensitivity and ability to work and thrive in a multi-cultural environment.
  • Proactive team player, able to take charge and follow-through.
  • Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
  • Proficient use of technology including RA tracking systems (TrackWise / SPS/MPD) - preferred

Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones. Occasional international travel (3-5x/year) may be required.

Minimum 32 hours per week available - full time preferred.

The Company

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

*Regulatory Affairs, regulatory CMC, RA, Labelling, regulatory compliance, pharmaceuticals*

 

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.

Apply for this job: EMEA RMC Professional /- Regulatory Affairs / RA - Pharmaceuticals

Contact Information:

Address:  Head Office
138 Southwark St, London 
SE1 0SW
England
Tel:  0207 928 2519
Website:  Visit Our Web Site

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