job description
Join Novo Nordisk Pharmaceuticals in Bali as the Associate Director, Head of Medical Affairs and Regulatory/Pharmacovigilance. This is a unique opportunity to lead a dynamic team and drive scientific excellence in a global healthcare leader. You will be part of the affiliate Leadership Team, playing a pivotal role in shaping the medical and regulatory strategies for our innovative therapies.
In this role, you will ensure compliance with local and international regulations, foster strong relationships with key stakeholders, and contribute to the development and implementation of medical affairs initiatives. Your leadership will be crucial in maintaining the highest standards of pharmacovigilance and regulatory affairs, ensuring patient safety and product efficacy.
Novo Nordisk is committed to changing lives for the better, and we are looking for a passionate and experienced professional to join us in this mission. If you are ready to make a significant impact in the healthcare industry, we invite you to apply.
Responsibility
- Lead and manage the Medical Affairs and Regulatory/Pharmacovigilance teams to ensure compliance with local and international regulations.
- Develop and implement strategic plans for medical affairs, regulatory affairs, and pharmacovigilance activities.
- Serve as the primary point of contact for regulatory authorities and key stakeholders, ensuring effective communication and collaboration.
- Oversee the preparation and submission of regulatory documents, ensuring accuracy and timeliness.
- Monitor and report on adverse events and product complaints, ensuring compliance with pharmacovigilance standards.
- Provide medical and scientific expertise to support the development and launch of new products.
- Collaborate with cross-functional teams to ensure the successful execution of medical and regulatory strategies.
- Stay abreast of industry trends and regulatory changes, providing guidance and training to the team as needed.
Qualifications
- Advanced degree in Medicine, Pharmacy, or a related field.
- Minimum of 10 years of experience in medical affairs, regulatory affairs, or pharmacovigilance, with at least 5 years in a leadership role.
- Strong knowledge of local and international regulations governing pharmaceutical products.
- Proven track record of successful regulatory submissions and approvals.
- Excellent communication and interpersonal skills, with the ability to build and maintain strong relationships with stakeholders.
- Strong analytical and problem-solving skills, with the ability to make data-driven decisions.
- Experience in leading and managing high-performing teams.
- Fluency in English; knowledge of Indonesian is a plus.