EMEA REGULATORY PROFESSIONAL, GLOBAL REGULATORY AFFAIRS (1 OF 2)

Johnson and Johnson is recruiting for an EMEA Regulatory Professional, Global Regulatory Affairs, located in Poland.
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.
nj.
om/.
The Regulatory Professional provides support to the EMEA Regulatory Leader (EURL)/EMEA Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio of the EMEA Established Products and Communicable Diseases team.
In this role, you are responsible for assigned projects to support regulatory activities associated with the development, post-approval and life-cycle management for designated products and provide regulatory strategic and operational support for products by interacting with project teams, LOCs and regulatory agencies and supporting CTA and MAA related submissions as appropriate.
Other key responsibilities include providing regulatory input and follow-up for inspections, audits, litigation support and products complaints, as well as guidance and support to product development teams on regulatory issues.
More detailed responsibilities include, but are not limited to.
Input in development, post-approval and life cycle management Liaison with Regulatory Agencies and Local Operating Companies Input in document and process development Responsibility for the critical review of submission documents to ensure compliance with regulatory requirements; Give regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints; Serve as the Regulatory representative on specific multi-discipline teams; Advise team on required documents and submission strategies in preparation of CTAs; Ensure CTA submission packages are complete and available according to agreed timelines; Review and approve clinical trial supply plans Advise team in required documents and submission strategies in preparation of Marketing Authorization Applications (MAA) as assigned (in collaboration with LOCs as appropriate) Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities; Provide support in portfolio optimization processes such as Delistings and Divestments.
Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.
Qualifications Qualifications Knowledge of regulatory requirements related to submissions and of filing registration process.
Understanding of CTA, MAA and eCTD dossier component requirements Knowledge of Microsoft programs as well as electronic management systems (e.
.
ERIS, GRAIL) Understands competitive landscape, e.
., views of HA, regulatory precedence, labelling differences and therapeutic area issues Knowledge of laws, guidances and requirements and their implications related to specific therapeutic areas Understands life cycle of drug product from discovery through marketing and post-approval requirements Basic medical/scientific understanding of clinical trials and drug development General knowledge of HA organizational structure and individual responsibilities in those structures Understanding of the drug development process and regulatory submission and approval process Understanding of end of Life Cycle activities such as Delistings and Divestments Knowledge of the regulatory environment, guidelines and practices of EMEA regions.
Required Education and Experience University degree – medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience; Experience in regulatory affairs; Able to work successfully within a team environment and as an individual contributor; Project management skills; Oral & written communication skills; Organisation & multi-tasking skills.
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.
areers.
nj.
om.
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.