Regulatory Affairs Country Lead

at  Johnson Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .
Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.
At Innovative Medicine, we never stop working toward a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension. Visit us: www.janssen.com

QUALIFICATIONS:

• Education: Bachelors Degree as a Pharmacist is mandatory
• Minimum 5 years of consolidated experience in Regulatory Affairs within Pharm multinational companies.
• Effective communication skills, with the ability to accurately convey information to peers, supervisors, teams, and external professional contacts.
• Strong cross-functional teamwork abilities.
• Consultative approach in providing expert advice on regulatory issues to internal clients.
• Proactive analysis of competitive information and collaborative strategizing with local brand teams to build consensus on regulatory approaches.
• Proficiency in project management, ensuring adherence to project timelines for new product filings, line extensions, and variations in line with business objectives.
• Creativity and adaptability in finding innovative solutions and approaches in a rapidly changing environment.
• Fluent English level is required
• Good understanding of key processes, guidelines, and frameworks related to Regulatory Affairs.

• Contributing to the development of regulatory strategies for both new and existing products to ensure successful regulatory approval for new product registrations and life cycle management, in accordance with marketing objectives.
• Establishing and maintaining effective communication channels between the Company and local Regulatory Agencies responsible for reviewing and approving new applications and maintaining existing licenses.
• Overseeing the approval process for promotional materials. –
• Acting as an internal consultant and facilitator on regulatory matters, providing expert guidance consistent with Company policies and local regulations governing medicinal products.
• Assessing and providing feedback on Health Authority policies and regulations