Regulatory Category Lead, Dermatology

vor 1 Woche

Basel, Basel-Stadt, Schweiz Bayer Vollzeit

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Regulatory Category Lead, Dermatology & Womens Intimate Health (M/F/d)

YOUR TASKS AND RESPONSIBILITES

  • Lead and manage the RA Category Team, Dermatology and Women's Intimate Health (WIH), including performance management, development, resource allocation and budget
  • Oversee the development and implementation of new product regulatory strategies, ensuring that the optimal regulatory classification is chosen to achieve the fastest route to market with the desired competitive claims
  • Ensure that Regulatory strategy and activities are aligned with key stakeholders
  • Create dossiers for new dermatology and WIH products and support the timely registration or notification, as required
  • Develop response strategies for requests for additional information
  • Monitor and influence relevant legislation. Ensure compliance with and/or leverage opportunities resulting from implementation of new legislation for new products under development
  • Direct and supervise all team interactions with Competent Authorities or Government bodies, as applicable
  • Participate as the regulatory expert in due diligence activities

WHO YOU ARE

  • A degree in the life sciences (postgraduate degree is preferred but not required)
  • At least 10 years relevant RA experience (including a minimum of one year's professional experience in EU medical device regulatory affairs or quality management)
  • Strong management and leadership skills
  • Excellent business acumen and strategic agility
  • Collaboration, influencing and negotiation skills
  • Problemsolving, analytical and project management skills
  • Demonstrated proficiency working in a deadline controlled, highly regulated environment
  • Desire to work in a complex, multicultural, fastpaced, setting
  • Ability to communicate effectively in English, both written and spoken
LI-CH

YOUR APPLICATION

Location:

Switzerland :
Basel-City : Basel

Division:

Consumer Health

Reference Code:

790247

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