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/.

We are looking for a highly motivated individual to join our local affiliate as a Regulatory Affairs Manager. In this position, you will play a crucial role in ensuring adherence to all regulatory requirements and successfully implementing our regulatory strategy. You will collaborate closely with cross-functional teams to create and implement regulatory plans that align with the company's goals and objectives.
Key Responsibilities:

• Ensures marketing authorizations and updates are in line with Regulatory Affairs requirements. Prepare and manage regulatory submissions and correspondence with regulatory agencies.
• Ensures an efficient collaboration with all Regulatory Affairs colleagues, internal and external and alignment with the EMEA regional Regulatory Affairs (GRA / ERMC) organization. Provides regulatory intelligence to company departments.
• Co-creates local regulatory strategy for new launches in coordination with local and regional partners. Ensure compliance with applicable regulations and guidelines.
• Acts as back-up for Bulgaria Regulatory Head for all activities, as needed. Supports RA Head in developing local regulatory strategic objectives, goals and performance measures.
• Represents department in external/internal audits and gets involved in actions derived from such audits that require RA actions; ensures a constant state of "inspection readiness".
• Creates and updates RA local procedural documents, as needed.

Experience and Skills we're looking for:

• Bachelor's Degree or equivalent, preferably in Pharmacy, Chemistry, Biology, or related Life Science.
• Minimum of 4 years of experience in regulatory affairs.
• Excellence in communication to authorities: understanding of regulatory legislative process and impact.
• Ability to work independently and collaboratively in a fast-paced environment.
• Outstanding attention to detail and ability to manage multiple projects simultaneously.
• Analytical and critical thinking. Able to make independent decisions.
• Ensuring RA and legal requirements are fully understood, appropriately managed and aligned with when planning projects, developing materials, driving projects and contracting vendors.
• Ensuring inspection readiness with respect to personal training compliance.
• Ability to independently plan, organize, co-ordinate, lead and implement assigned tasks.
• Excellent interpersonal skills (oral, business writing, communicating and listening).
• Native Bulgarian speaker and proficient English knowledge of both spoken and written.
• Professional experience from pharmaceutical business environment.

If you are a motivated and ambitious individual with a passion for regulatory affairs, we would love to hear from you. Join our world-class team at Johnson & Johnson and make a difference in the lives of millions of people around the world.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.