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Assoc Dir Regulatory Affairs - 7197

Date: Jan 5, 2019

Location: Haarlem, NL, 2011 KA

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

Job Function

As the Associate Director Regulatory Affairs you will be accountable for leading the development and implementation of regulatory strategy. You will show strategic leadership skills, and a deep understanding of global regulatory science. You support the site, by taking all regulatory and advisory steps needed in order to avoid any production disruptions thus keeping each product on the market. Maintain the dossiers to meet all regulatory requirements and match the registered information and the reality of the site (variation/change control)

With this role you will be a Site Leadership Team Member, serving as an influential member of the site leadership team, who impacts decision making and takes an active role in promoting cross-site initiatives, team work and collaboration across site functions. The function has a direct reporting line to the Site GM and an indirect functional reporting line to the regional Senior Director Site Regulatory Affairs.

Job Responsibilities & Person Specification

  • Identifying applications of functional knowledge and existing methodologies to complex problems
  • Serving as an expert within own function
  • Leading functional teams or projects and serving as a best practice/quality resource
  • Is recognized as an expert in own area within the organization
  • Requires specialized depth and/or breadth of expertise
  • Interprets internal or external business issues and recommends solutions/best practices
  • Solves complex problems; takes a broad perspective to identify solutions
  • Works independently, with guidance in only the most complex situations
  • In-depth business acumen and problem solving skills.
  • Extensive experience leading people, teams and projects through complex environments
  • Onboarding and coaching of new hires

Person Specification

  • Excites and energizes around the way forward.
  • Challenges to break through the limitations of the current ways of working.
  • Encourages others to explore difference and seek new ideas.
  • Inspires others to achieve things beyond expectations.
  • Champions, and supports continuous improvement, especially with regard to OPEX processes and procedures.
  • Develops and unlocks the creativity of individuals and teams to solve problems and implement creative and innovative solutions.
  • Extensive experience within the relevant Regulatory Affairs area of focus (Strategy/CMC/Operations/ Intelligence/La

Qualifications

  • Masters’ Degree (or equivalent) in a related field.
  • PHD Preferred but not essential.
  • Potential flexibility on requirements depending on experience.
  • Minimum 5 Years’ experience in a regulatory Pharmaceutical position.

 

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

In process of validation

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.