You lead global regulatory strategies and ensure compliance while coordinating with regional teams. Your role involves managing submissions and interactions with health authorities to facilitate timely approvals.
Anforderungen
- •Bachelor's degree in Life Sciences.
- •Master's degree in Pharmacy.
- •Significant experience in regulatory affairs.
- •Proven track record in project management.
- •Experience in cross-functional settings.
- •Strong knowledge of clinical trials.
- •Excellent problem-solving skills.
- •Excellent negotiation skills.
- •Excellent communication skills.
- •Detail-oriented in managing projects.
- •Skilled in risk management.
- •Experience with cross-functional teams.
- •Ability to influence Health Authority interactions.
- •Fluency in English is essential.
Deine Aufgaben
- •Lead implementation of regulatory strategies globally.
- •Provide strategic input for global regulatory plans.
- •Align regional regulatory approaches with global objectives.
- •Define and manage Health Authority interaction strategies.
- •Oversee planning and submission of regulatory dossiers.
- •Liaise with local Health Authorities for approvals.
- •Develop strategies to minimize review delays.
- •Ensure timely responses to Health Authority queries.
- •Contribute to departmental goal setting and initiatives.
- •Ensure compliance with internal policies and regulations.
Deine Vorteile
Personal and professional support
Original Beschreibung
# Senior Global Program Regulatory Manager
**Basel (City)** | **Full time**
**Job Description Summary**
# LI-Hybrid (3 days per week on-site)
Location: Basel, Switzerland
We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs team. The role involves directing the development and submission of regulatory documents, providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products, and serves as a regulatory liaison throughout the product lifecycle.
**Job Description**
**Major accountabilities:**
* Lead the implementation of regulatory strategies and operational activities across major global regions.
* Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents.
* Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams.
* Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials.
* Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans).
* Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals.
* Develop and implement strategies to minimize review delays and regulatory clock stops.
* Ensure timely and compliant responses to HA queries and requests.
* Contribute to departmental goal setting and lead initiatives to improve regulatory processes.
* Ensure adherence to internal policies, SOPs, and global regulatory requirements.
**Minimum requirements:**
* Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
* Significant experience in regulatory affairs within the pharmaceutical industry.
* Proven track record in project management and regulatory operations.
* Experience representing the organization in cross-functional and cross-cultural settings.
* Strong knowledge of clinical trials, drug development, and regulatory compliance.
* Excellent problem-solving, negotiation, and communication skills.
* Detail-oriented with the ability to manage complex regulatory projects.
* Skilled in risk management and working with cross-functional teams.
* Ability to navigate and influence Health Authority interactions.
* Fluency in English (written and spoken) is essential.
**Commitment to Diversity and Inclusion/EEO**
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
**Accessibility and Accommodation**
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
**Skills Desired**
Clinical Trials, Cross-Functional Teams, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Problem Solving Skills, Regulatory Compliance, Risk Management