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Johnson and Johnson is recruiting for a Regulatory Affairs Specialist, to be located in our Madrid office. This position has a hybrid working model.

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/.

The skills you'll use every day required for this role are aligned with the J&J Leadership Imperatives competencies and with our Local Affiliate Competencies. Under supervision of the Head, the RAP is responsible for regulatory activities to support and grow the business in line with the company goals. This includes:

• Support in obtaining and maintaining marketing authorizations.

• Ensure regulatory compliance.

• Professionals are backup for the Experts for CVT meetings and can attend CVT meetings for late lifecycle products as part of their personal development program.

Main Responsibilities

Departmental management

• Handling incoming and outgoing correspondence including archiving.

• Maintain the local product files in line with current registered authorization details according to the relevant local and EU legislation.

• Maintain updated lists & tables shared with other departments

New and existing products

• Prepare and submit regulatory submissions with support from regulatory operations.

• Ensure deadlines for different projects are met or raised to Head of RA

• Participate in internal working groups as required and address any regulatory actions with senior RA colleagues.

• Maintain the product label and packaging in line with current registered authorization details according to the relevant local and EU legislation

• To perform all required operational product tasks, following the plan and updates from EMEA and TA Experts

• Translating activities for the Product Information of the assigned products.

• Distribution of the new versions of the Summary of Product Characteristics to other departments of the company.

• Artwork management activities.

Compliance

• Contribute to compliance with all regulatory requirements (e.g. timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOP’s & supporting systems …)

• Maintain an awareness of regulatory guidelines/directives/national requirements

Internal contacts

• Support other departments based on their needs (logistic, quality, pricing, medical, marketing, sales, customer services, legal department, HCBI)

• Support tender business

External contacts

• Ensure positive interaction in any communication with the local health authority, in general and on product-specific topics.

• Maintain up to date the Licensees

Miscellaneous

• Support and contribute to GRA-EMEA initiatives

• Contribute to initiatives around lessons learnt and change management to ensure efficiency gains

Out of scope for FTE calculation, but potentially part of responsibilities

• Revision and approval of the Promotional Materials of the assigned products if applicable.

• Report all suspected adverse reactions, serious or non-serious, I may be aware of within a maximum of 24 hours after being aware of it and communicate it to the Pharmacovigilance Department.

Additionally, for all employees involved in Research Related Activities (RRA):

• Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and appropriately managed when planning projects, developing materials, completing projects and contracting vendors.

• Ensure HCC and legal requirements (Fair Market Value, Transfer of Value rules, Promotional Materials rules) are fully understood, appropriately managed and aligned with when planning projects, developing materials, completing projects and contracting vendors.

• Ensure inspection readiness with respect to personal training compliance, and availability of CV (Summary of Experience) and individualized Job Description.

Qualifications

Minimum Qualification

• University degree in Pharmacy, Biology, Chemistry or related Life Science

• Regulatory Affairs experience (0-3 years) at operational level

• Direct experience and knowledge of general regulatory requirements and guidelines

Other requirements

• Fluent in Spanish and English

• In depth knowledge of regulations/legislation

• Strong in data gathering & interpretation

• Analytical, detail driven

• Good communicator

• Constructive team player

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.