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

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

Overall purpose of job:

Dedicated to (a set of) Therapeutic Areas, the analyst RA Professional EMEA EM Algeria has responsibility for regulatory activities and strategy setting registration of new products, launch readiness, promotional material approval, and Life cycle management including renewals and variation dossiers preparation and regulatory intelligence along with maintaining a high level of compliance Ensure registration of new products/presentations and maintenance of marketed ones.

Essential duties and responsibilities:

Registration activities:

In collaboration with the regional RA and global functions as appropriate, propose and implement the local submission planning & strategy and report the status to relevant business partners. Coordinate the local preparation, review, submission, and follow-up of regulatory files in compliance with local regulations. Prepare local/administrative sections. Submit regulatory files (including but not limited to: New MA dossiers, renewals, variations, response to questions) to local Health Authorities and ensure that filing and submission meet local requirements and company objectives.

Promotional material compliance:

Review and approve promotional material intended for local use, to ensure compliance with the local regulation and J& J guidelines & policies. Submit, as appropriate, promotional material to Health Authorities and follow-up for efficient approval to support commercial activities. Archive promotional material and maintain a formal list of valid material.

Regulatory intelligence and knowledge management:

Anticipate, detect, assess, report and follow new or updated regulations and guidelines that may have an impact on local activities as well as critical information for business & strategy (e.g. competitors status). Develop & maintain relationships with Health Authorities & other relevant organizations. Maintain correspondences and other records of all filings and interactions with regulatory authorities. Implement and manage archiving of local regulation documentation. Populate and update appropriate J& J databases as per J& J processes.

Daily business & product supply Support:

In compliance with J& J guidelines, answer specific Health authorities’ requests and prepare, as appropriate, the relevant regulatory dossiers (e.g. Importation requests, NPP, clinical trials application, etc.). Develop and update local packaging material as per regulatory requirements. Provide regulatory support to all company functions upon request. Support Finance department and budget follow-up. Ensure that all regulatory activities are conducted in compliance with relevant laws & regulations as well as J& J guidelines. Report Adverse Event & product quality complaints as per J& J Pharmacovigilance guidelines. Comply with local laws & HCBI guidelines, Foreign Corrupt Practices Act (FCPA), Policy on Business Conduct (PBC).

Compliance Responsibilities

Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and, where applicable, appropriately managed when planning projects, developing materials, executing 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, where applicable, complied when planning projects, developing materials, executing projects and contracting vendors. Ensure inspection readiness with respect to personal training compliance, and availability of recent CV and individualized Job Description.

Special requirements:

Fluent in Arabic, French and English.

Degree in Pharmacy

Experience in regulatory affairs

Excellent communication and presentation skills, both verbal and written