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Job Details

Director/Senior Director – Global Regulatory Labelling

Company: RBW Consulting
Location: San Rafael, California
Reference: RAA-DSDGRL-SRCA
Closing Date: 10 Dec 17
Type: Full Time
Salary (£): 100,000+
Benefits: Competitive Benefits Package

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Requirements:

Director/Senior Director – Global Regulatory Labelling

California, USA

SUMMARY

The Director/Senior Director of Regulatory Global Labelling (REG-GL) is a strategic role leading the development of labelling for products worldwide. Responsibilities may include developing the strategy for labelling content for Target Product Profiles, Company Core Data Sheets, Prescribing Information, Patient Labelling, and Instructions for use.

The incumbent will be responsible for regulatory compliant, competitive, and up-to-date labelling. The Director/Senior Director of REG-GL provides regulatory labelling leadership to the labelling team and cross functional teams where Regulatory labelling membership is required. Manage the strategic regulatory labelling health authority interactions labelling negotiations worldwide.

The Director/Senior Director is responsible for ensuring the execution of global regulatory labelling are aligned with the global regulatory strategy and corporate goals. Oversees and mentors labelling professionals to achieve regulatory objectives.

This position will be responsible for:

RESPONSIBILITIES

  1. Providing regulatory strategic guidance and oversight of global labelling activities for the client’s commercial products and development products in the metabolism and endocrinology, cell and gene therapy other therapeutic areas as assigned.
  2. An active member on regulatory, development, and commercial teams supporting the strategy and identify requirements to ensure labelling claims support the regulatory plans and are in-line with corporate goals.
  3. Lead the labelling teams, which will include participants around the globe.
  4. Ensuring commercial product labelling is compliant with the worldwide regulations and procedures.  
  5. Create and lead the development of labelling processes at the client.
  6. Present strategic global labelling issues to Regulatory Management and Executive Management on an ad-hoc/issue-driven basis for assigned projects/products.
  7. Provide strategic input on interpretation and implementation of key regional labelling regulations, guidelines, and best labelling practices, and align with global strategic labelling plan.
  8. Responsible for the development of labelling negotiations strategic plan for the assigned therapeutic area(s) and conduct health-authority reviews and label negotiations (in writing, phone or in person as needed). Lead US and EU labelling negotiations for the assigned products.  Guide/ support REG International for all labelling related HA negotiations and participate in labelling negotiation meetings or teleconferences with HAs, as needed.
  9. Oversight and leadership of the International labelling and compliance with CCDS, local requirements, business strategies, and overall quality. 
  10. Lead or direct the creation of high quality documents supporting changes to the CCDS or local labelling with internal and/or external experts including responses to labelling-related Health Authority queries.  Review of summary documents such as clinical overviews to ensure the labelling message is consistent with the overall representation of a marketing application.
  11. Present and defend proposed labelling changes in global product information documents, including labelling documents in key markets to Senior Management as required for review and approval.
  12. Interactions with RA worldwide: Interact with Regulatory International and regional Partners to ensure timely implementation of global labelling changes and new market submissions and approvals.
  13. Guide launch teams on launch strategy for new commercial products.  Provide Supply Chain and QA guidance on labelling implementation requirements.
  14. Ensure all labelling documents are of the highest quality and represent the safe and effective use of the product.

EXPERIENCE

Required Skills:

A minimum of 12 years required of industry experience and extensive experience (at least 4-6 years) in global labelling, alternatively extensive experience in related areas of the Pharmaceutical Industry or Health Authorities.

  • Experienced leader with management and direct reports.
  • Experience negotiating with internal and external stakeholders on complex regulatory issues of importance to the client.
  • Seasoned regulatory professional with experience in submissions for products in development and commercial products.
  • Thorough understanding of regulatory labelling requirements and strategic labelling planning.
  • Outstanding interpersonal and communication (written and verbal) skills.
  • Attention to detail and highly organized.
  • Prior experience leading cross functional teams.
  • History of solving regulatory labelling related problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
  • Fluency in English as business language, additional languages advantageous.

Desired Skills:

  • Expertise in global labelling and managing project teams including international teams (not in the same time-zone).
  • Biologics and rare disease experience is desirable.
  • US and/or EU labelling expertise required and International and Core Labelling experience preferred.

EDUCATION

Minimum requirements Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Apply for this job: Director/Senior Director – Global Regulatory Labelling

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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