Senior Associate Regulatory Affairs

For one of our clients we are looking for a Senior Associate Regulatory Affairs.

  • Do you have experience in the review of Promotional material and know the Dutch code?
  • Are you pro-active and can work independent?
  • Do you have a “can do” mentality?
  • Do you have a background in Pharma or Medical biology with 2+ years RA experience?

Then you might be the candidate we are looking for! Don't hesitate to apply now!

Job Description 

Provide local Regulatory Affairs Expertise on assigned products by

  • Reviewing promotional materials.
  • Reviewing and approving source text for country labeling and country artwork
  • Providing regulatory advice to local and regional teams upon request
  • Acting as point of contact for the regulatory authorities
  • Acting as a back-up for the RA Lead.
Responsibilities 

Local Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all clients molecules.
The Local Regulatory Representative (Sr. Associate) is assigned to one or more products and may support an LRR or lead a program under the supervision of an experienced Local Regulatory Lead.

  • Assist in aligning local regulatory requirements with the clients corporate standards.Provide national input to regulatory strategies.
  • Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
  • Ensure local labels are developed and maintained in line with local legislation and the clients standards and procedures.
  • Act as the point of contact with regulatory agencies.

STRATEGIC AND EXECUTION

  • Ensures local regulatory submissions are made on time and meet the clients corporate and local regulatory requirements.
  • Creates, reviews and approves source text for country labeling, and owns the country artwork based on source text.
  • Reviews and approves the promotional and non-promotional materials.
  • Monitors changes in the local Trade Associations/national legislation and forwards information to local/regional groups communicating the impact to the client.
  • Monitors the external regulatory environment to help inform/advise in the regulatory decision making.

HEALTH AUTHORITY INTERACTIONS

  • Acts as the point of contact with regulatory agencies in fulfilling local obligations.
  • Participates/contributes to local agency interactions and their preparation.

COMMUNICATION AND COLLABORATION

  • Works closely with cross-functional colleagues in the affiliate to align on strategy and deliver affiliate goals.
  • Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.
  • Partners with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of assigned clients molecules.
  • Partners with peers to ensure consistency on procedures.
  • Acts as contact and create relationships with Agency staff on specific product assignment.

COUNTRY SPECIFIC ACTIVITIES

  • Participates in local regulatory process improvements, initiatives and training.
Profile 
  • Demonstrate ability to work in teams.
  • Good communication skills
  • Attention to detail
  • Ability to understand and communicate scientific/clinical information
  • Master’s degree (scientific area) OR
  • Bachelor’s degree (scientific area) and 2 years of directly related experience.
  • Degree and in-depth regulatory experience and/or related to EU/the Netherlands.
  • Depth knowledge of EU/Dutch legislation and regulations relating to medicinal products.
Contact Information 

Kristin Deneckere
+32 15 21 11 04
kristin.deneckere@valesta.com

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