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regulatory affairs specialist

AbbVie

<div>
 
 
 Purpose Statement
 
 
 
 The role of Regulatory Affairs &amp; Clinical Operations Assistant is to partner with the business to drive the appropriate administrative and logistical support in a timely and efficient way.
 
 
 
 
 
 
 Responsibilities:
 
 
 
 
 
 
 
 
 Regulatory Affairs:
 
 
 
 <ul>
 <li>
 The administrative assistant is expected to build a solid partnership with financial controller and play a gate-keeper role in the P2P process. This includes challenging back the stakeholders on any wrong practice, counseling on the right steps to follow, setting the right expectations with vendors and providers, validating all steps are executed in compliance with company requirements and subsequently leveraging excellence in events and execution.
 </li>
 <li>
 Creating Shopping Carts, Purchase Orders, IOs.
 </li>
 <li>
 Requesting PO uplifts when needed.
 </li>
 <li>
 Tracking and following up on the budget with finance department.
 </li>
 <li>
 Submitting and receiving RA originals, documents, and files in EDA.
 </li>
 <li>
 Receiving all samples needed from distributers for Regulatory Affairs Department.
 </li>
 <li>
 Receiving invoices from vendors, reviewing and sending them for posting.
 </li>
 <li>
 Drafting agreements of different vendors and following up with Legal Team.
 </li>
 <li>
 Documenting department&rsquo;s expenses of all the services.
 </li>
 <li>
 Sending Monthly Free Medical Samples Report to EDA for Regulatory.
 </li>
 <li>
 Supporting in business diner/event/travel arrangements.
 </li>
 <li>
 Communicating with Travel agencies to receive quotations.
 </li>
 <li>
 Supporting with hard and soft archiving.
 </li>
 <li>
 Scanning and printing essential documents and sending them to the team.
 </li>
 <li>
 Arranging the inspectors&rsquo; visits in terms of timing, transportation, location and expenses and coordinating with the vendor.
 </li>
 <li>
 Preparing variety of written materials.
 </li>
 <li>
 Operates and maintains files, ensuring security/confidentiality at all times.
 </li>
 <li>
 Adds new vendors, HCPs, and updates vendors&rsquo; information when needed through Ariba &amp; DSP.
 </li>
 <li>
 When dealing with health care providers, the administrative assistant is expected to manage accurately and timely the transactions related to the stakeholders in line with ethics and compliance procedures in place, among others: Sponsorship Agreements, Contracts, Events Logistics Support, MAP support, Appropriate List of Attendees and Attendance Proofs, etc&hellip;
 </li>
 </ul>
 
 
 
 
 
 
 Clinical Operations:
 
 
 
 <ul>
 <li>
 The Clinical Administrative Assistant provides administrative and clinical management support to Site M&amp;M personnel and assist them with the in-house organization, management and execution of projects and activities undertaken by Clinical Operations Site Management &amp; Monitoring personnel assigned to clinical studies conducted within the country.
 </li>
 <li>
 If applicable, creates a local trial file for the filing of Country specific original documentation and archiving system.
 </li>
 <li>
 Supports local Clinical Team with the handling of Essential Documents, including Contracts and Archiving. Ensures the Investigator Site Files are crated, contain the correct and complete documentation, and are shipped as appropriate to the Investigational Sites.
 </li>
 <li>
 In-house support for CRAs during site visits (administrative tasks, point of contact etc.)
 </li>
 <li>
 Acts as in-house support for CRA&rsquo;s with the handling and destruction arrangements of Investigational Product as, and if, required.
 </li>
 <li>
 Participates in pre-audit activities. Supports CRAs to ensure audit and inspection readiness in clinical activities of responsibility.
 </li>
 <li>
 Supports Clinical Team in travel arrangements. Supports with organizing Team Meetings (booking meeting rooms, taking minutes and organizing catering etc.). If appropriate, assists with the filing of training records and other relevant personnel documentation for staff.
 </li>
 <li>
 May interface with and build professional collaborative relationships with: Local personnel including Medical Department personnel and other AbbVie personnel within Clinical Operations as well as Regulatory, Finance and Legal Functions, Human Resources, administrative staff and other relevant functional areas.
 </li>
 <li>
 Site Management and Monitoring personnel in other Countries and Document Management. External service providers &bull;Study personnel (investigators, study coordinators, pharmacists, etc.)
 </li>
 <li>
 Peers within the organization vendors.
 </li>
 <li>
 Supports CRAs with the CA and EC submissions of clinical studies and related amendments, including collection of essential documents.
 </li>
 <li>
 Creates Shopping Carts, Purchase Orders, and ACRs and following up till receiving the proof of payments/ cheques.
 </li>
 <li>
 Requests PO uplifts when needed.
 </li>
 <li>
 Creates quarterly Breakdowns (Internal and External) for clinical studies different sites.
 </li>
 <li>
 Creates Annual Breakdowns for the estimated governmental payments.
 </li>
 <li>
 Creates Quantum invoices for clinical studies.
 </li>
 <li>
 Keeping the payment tracker up to date.
 </li>
 <li>
 Assisting with investigators site and vendor payments according to local finance processes and Quantum.
 </li>
 <li>
 Ensuring financial information and documents for assigned studies and sites are entered into SAP in a timely manner and is managed in compliance with company policies.
 </li>
 <li>
 Submits files and cheque payments to MOH, EDA, and different investigator sites .
 </li>
 <li>
 Supports Clinical Team in uploading approvals on Veeva Vault.
 </li>
 <li>
 Communicating with principal investigators of clinical trials to support in administrative work or handling issues.
 </li>
 <li>
 Supports CRAs with the CA and EC submissions of clinical studies and related amendments and annual renewals.
 </li>
 <li>
 Orders stationery items or any needed materials.
 </li>
 </ul>
 
 
 
 
 
 
 Qualifications:
 
 
 
 <ul>
 <li>
 University degree, preferred pharmacy or dentistry.
 </li>
 <li>
 If scientific field to be fresh graduate.
 </li>
 <li>
 0 - 2 years of experience in administrative support in a multinational environment with the same level of complexity.
 </li>
 <li>
 Very strong communication skills.
 </li>
 <li>
 Strong competency in using Word, Power Point, Outlook, Adobe, and other internet platforms used in managing business transactions such as SAP, or others.
 </li>
 <li>
 Ability to work cross functions with multiple stakeholders, with very solid prioritization skills and time management as well as confidence and assertiveness.
 </li>
 <li>
 Capability to work under pressure while maintain the right level of accuracy and efficiency.
 </li>
 </ul>
 
 
</div>

Regulatory Affairs & Clinical Operations Assistant (Contractor)

Kellanova

<div>
 
 
 At Kellanova we are immersed in a performance culture that drives business growth, where you are given the opportunity to thrive and are empowered to do more than you imagined.
 
 
 
 
 
 
 We are a global powerhouse in cereals and snacks and we make some of the world&rsquo;s favourite foods! Our iconic brands include Corn Flakes, Frosties, Coco Pops, Special K and Pringles.We continue to innovate and stay close to our customers to remain on top of the game!
 
 
 
 
 
 
 Purpose of the role
 
 
 
 As a Regulatory and Wellbeing Affairs Assistant Manager, you will be responsible for supporting Egypt and Africa region and working closely with marketing, supply chain, R&amp;D teams and all other areas of the business.
 
 
 
 Scope of work:
 
 Egypt, African countries (North Africa: Morocco, Algeria, Tunisia, Libya, East Africa: Kenya, Uganda, Ethiopia, Tanzania), other rest of Africa markets as business expands.
 
 
 
 
 
 
 Regulatory Support:
 
 
 <ul>
 <li>
 Work closely with R&amp;D and business partners regarding regulatory matters.
 </li>
 <li>
 Work closely with Product development, marketing, legal and all relevant teams to ensure local regulatory and external requirements, restrictions and risks are identified, accurate, relevant and timely input given to innovation projects.(These could be in areas of claims, labeling, permitted additives/formulations, new product regulations.)
 </li>
 <li>
 Performs regulatory compliance assessments for the markets of scope.
 </li>
 <li>
 Performs technical registrations across markets of scope through preparing registration files and applying at the government bodies responsible for registration.
 </li>
 <li>
 Understands external environment and regulatory developments, supports on building lobbying plans, advocacy priorities and actions aligned with relevant interfaces (legal, R&amp;D..)
 </li>
 <li>
 Implements advocacy plans for regulatory change or new product regulations.
 </li>
 <li>
 Represent the function in external platforms on technical issues, lobby activities and approvals to support aligned and agreed lobby/advocacy topics.
 </li>
 <li>
 Provides RA input on the topic and helps to implement the communication plan with other functions locally.
 </li>
 </ul>
 
 
 
 
 
 
 Wellbeing Support:
 
 
 
 <ul>
 <li>
 Propose / calculate the nutrition facts of recipes/breakfasts/snacks with our products, comparison with other traditional options.
 </li>
 <li>
 Assist in compliance with nutrition regulations and self-governance, localization of substantiation for claims (TV, print, web, POS).
 </li>
 <li>
 Management of a nutrition database of Kellogg&rsquo;s products in the region, populating it with renovations and innovations
 </li>
 </ul>
 
 
 
 
 
 Your Recipe for Success
 
 
 <ul>
 <li>
 A Scientific degree (Pharmacy, Science..), a nutrition degree is a plus.
 </li>
 <li>
 Should have a minimum 1-3 years of experience in Regulatory Affairs/Nutrition Function in a Food Industry.
 </li>
 <li>
 Ability to be a team player in support of the team and the business.
 </li>
 <li>
 Ability to organize and coordinate
 </li>
 <li>
 Ability to work in a high-pressured environment with tight deadlines
 </li>
 <li>
 Analytical thinking with the ability to plan, prioritize and deliver results
 </li>
 <li>
 Knowledge of the health agenda in food and nutrition and awareness of key players in the Reg and wellbeing debate
 </li>
 <li>
 Good Language Skills / Vocabulary in written and spoken English and preparation of Techno legal drafts. Any other languages like French is a good to have.
 </li>
 </ul>
 
 
</div>

Regulatory and Wellbeing Affairs Assistant Manager

Sobi - Swedish Orphan Biovitrum AB (publ)

<div>
 
 Company Description
 
 
 
 
 
 Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!
 
 
 
 
 At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.
 
 
 Here At Sobi, Our Mission And Culture Get Us Excited To Come To Work Every Day, But Here Are a Few More Reasons To Join Our Team
 
 
 <ul>
 <li>
 Competitive compensation for your work
 </li>
 <li>
 Emphasis on work/life balance
 </li>
 <li>
 Collaborative and team-oriented environment
 </li>
 <li>
 Opportunities for professional growth
 </li>
 <li>
 Diversity and Inclusion
 </li>
 <li>
 Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
 
 
 </li>
 </ul>
 
 Job Description
 
 
 
 <ul>
 <li>
 Prepare and manage Marketing Authorisation Applications (MAA) for Sobi products in GCC Region, including submission to Health Authorities via national or centralised procedures.
 </li>
 <li>
 Assess and process variations, renewals, and CMC changes for products and manufacturing sites across GCC/ME region, ensuring compliance with regulatory requirements.
 </li>
 <li>
 Maintain up-to-date product files and regulatory documentation, including labels and leaflets, to meet internal and external requirements.
 </li>
 <li>
 Monitor and report on regulatory activities, including significant changes in the regulatory environment, and prepare monthly reports.
 </li>
 <li>
 Optimise approval timelines by effectively managing file evaluations and liaising with Health Authorities.
 </li>
 <li>
 Ensure compliance with national legislation, international and local regulatory guidelines, and internal requirements whilst optimising company resources.
 </li>
 <li>
 Provide regulatory advice and support to internal stakeholders, ensuring quality standards are met and submissions adhere to strict deadlines.
 </li>
 <li>
 Perform additional Regulatory Affairs duties as requested by the manager.
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 Required Qualifications:
 
 
 <ul>
 <li>
 Bachelor's degree in pharmacy
 </li>
 <li>
 Minimum of 2 years' experience in Regulatory Affairs within pharmaceutical companies
 </li>
 <li>
 Familiarity with SFDA guidelines and regulatory requirements in GCC countries
 </li>
 <li>
 Experience managing variations, renewals, labelling updates, and other LCM submissions
 </li>
 <li>
 Strong written and spoken English skills
 </li>
 <li>
 Ability to handle multiple projects and adapt to changing regulatory requirements
 </li>
 <li>
 Excellent soft skills and presentation abilities
 
 
 </li>
 </ul>
 
 Desired Qualifications
 
 
 
 <ul>
 <li>
 GCC and/or Middle East working experience
 </li>
 <li>
 Arabic language proficiency
 </li>
 <li>
 Knowledge of Health Authority requirements in Middle East countries
 
 
 </li>
 </ul>
 
 Additional Information
 
 
 
 All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.
 
 
 
 Why Join Us?
 
 
 
 We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we&rsquo;re ready to take on the world&rsquo;s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others&rsquo; lives because that&rsquo;s exactly what we do here. If you&rsquo;re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
 
 
 We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.
 
 
 
 Sobi Culture
 
 
 
 At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.
 
 
 As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can&rsquo;t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
 
 
 
 An Equal Opportunity Employer
 
 
 
 Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.
 
 
 
 Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to talentacquisition@sobi.com.
 
</div>

Regulatory Coordinator

Sanofi

<div>
 <ul>
 <li>
 About the job
 
 
 </li>
 </ul>
 Supply Chain Function ensures product availability and distribution efficiency, through managing end-to-end supply chain operations, coordinating with local warehousing and logistics partners, implementing global supply chain strategies to ensure supporting business continuity and supply chain resilience.
 
 
 
 About Sanofi
 
 
 
 We&rsquo;re an R&amp;D-driven, AI-powered biopharma company committed to improving people&rsquo;s lives and delivering compelling growth. Our deep understanding of the immune system &ndash; and innovative pipeline &ndash; enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people&rsquo;s lives.
 
 
 
 Main Responsibilities
 
 
 
 <ul>
 <li>
 Coordinate and prepare for EDA inspection visits, including dossier compilation, logistics, and documentation.
 </li>
 <li>
 Submit and follow up on NORCB pre-evaluation files until final reports are issued.
 </li>
 <li>
 Oversee sample submission and analysis at NORCB, ensuring timely release of conformity reports.
 </li>
 <li>
 Track and manage all supporting documents (e.g., CPPs, GMPs) required for product release.
 </li>
 <li>
 Maintain accurate records and archives of all submissions, reports, and communications.
 </li>
 <li>
 Ensure compliance with all applicable regulatory guidelines and internal procedures.
 </li>
 <li>
 Manage procurement and timely delivery of reagents, reference standards, and other analytical materials for batch release.
 </li>
 <li>
 Support regulatory activities by coordinating sample withdrawals for new registrations, renewals, and variations.
 </li>
 <li>
 Act as the focal point for post-marketing surveillance of imported products with the EDA.
 </li>
 <li>
 Oversee the importation process in alignment with EDA regulations.
 </li>
 <li>
 Ensure adherence to HSE and compliance standards..
 
 
 </li>
 </ul>
 
 About You
 
 
 
 <ul>
 <li>
 Education: Bachelor&rsquo;s degree in Pharmaceutical Sciences or a related medical field.
 </li>
 <li>
 Experience: Minimum 4 years in regulatory affairs, quality assurance, or a related field within the pharmaceutical industry.
 </li>
 <li>
 Skills: Strong command of English (written and spoken)
 </li>
 <li>
 Proficient in Microsoft Office
 </li>
 <li>
 Excellent communication and negotiation skills
 </li>
 <li>
 Strong organizational and planning abilities
 </li>
 <li>
 Ability to manage multiple priorities under pressure
 </li>
 <li>
 Effective cross-functional collaboration and problem-solving skills
 </li>
 <li>
 Ability to meet deadlines
 </li>
 <li>
 Teamwork
 </li>
 <li>
 LEAD competencies: Act for Change, strive for results, Cooperate Transversally, Commit to Customer
 
 
 </li>
 </ul>
 
 Why choose us?
 
 
 
 Ready to push the limits of what&rsquo;s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.
 
 
 <ul>
 <li>
 Make your work count by supporting a company that brings life-changing treatments to millions &mdash; and is committed to doing right by patients, communities, and the planet.
 </li>
 <li>
 Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably.
 </li>
 <li>
 Support teams across science, medicine, and operations by building better systems, shaping bold strategies, and enabling innovation at speed.
 </li>
 <li>
 Make an impact across borders and functions, collaborating with leaders to turn complex challenges into real-world solutions.
 </li>
 <li>
 Advance your career through stretch roles, cross-functional moves, and development opportunities designed to match your ambition.
 </li>
 <li>
 Thrive in inclusive, high-performing teams where every role matters and every voice helps shape what&rsquo;s next.
 
 
 </li>
 </ul>
 null
 
 Pursue
 
 
 Progress
 
 .
 
 Discover
 
 
 Extraordinary
 
 .
 
 
 Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what&rsquo;s never-been-done-before. You&rsquo;ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people&rsquo;s lives? Let&rsquo;s Pursue Progress and Discover Extraordinary &ndash; together.
 
 
 At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
</div>

Logistics Coordinator (1 year contract)

Sandoz Egypt

<div>
 
 Job Description
 
 
 
 <ul>
 <li>
 3 years&rsquo; experience in the regulatory field (new submission/ maintenance activity/ pricing) in assigned market(s).
 </li>
 <li>
 Review and compile the registration dossier in cooperation with the Regulatory Competence Centre (RCC) department and the local relevant stakeholders to fulfil the local requirements and ensure smooth and rapid submission and approval of the files, in a timely manner, in line with the registration planning cascaded by the line manager and DRA Head.
 </li>
 <li>
 Review and Validation of the promotional and educational materials against health authority regulations and approved product information and obtaining the authority approvals when applicable.
 </li>
 <li>
 Communicate the deficiency letters raised by the health authorities to line manager and DRA Head and relevant global stakeholders during evaluation within the specified timeframe.
 </li>
 <li>
 Ensure supply continuity of the registered products by securing the timely submissions and approvals of the variations and requesting special importation permit from HA when needed.
 </li>
 <li>
 Maintain all market artworks in coordination with the labeling responsible and manufacturing site in alignment with the country regulations and approved product information.
 </li>
 <li>
 Ensure execution of Pharmacovigilance and patient safety regulatory activities in compliance with the relevant SOPs and local HA regulations.
 </li>
 <li>
 Ensure that product patient information leaflets are updated according to the latest CDS update approved in the country of origin by securing timely submission in alignment with the relevant SOP.
 </li>
 <li>
 Complete and regular archiving the registration files, authorities correspondence and relevant documents.
 </li>
 <li>
 Monthly reporting of the activity, regular and accurate updating of the tracking tools.
 </li>
 <li>
 Regulatory intelligence database update with close follow up of the latest circulars and guidelines issued by the health authorities, and immediate gap assessment and timely implementation within the company when applicable.
 </li>
 <li>
 Contribution in overall strategy building, planning and execution of market activities to achieve the overall market(s) TGT and objectives.
 </li>
 <li>
 Support in onboarding and guidance of any new joiners in GLS DRA team.
 </li>
 </ul>
</div>

DRA Senior Associate, Gulf

Johnson & Johnson Innovative Medicine

<div>
 At Johnson &amp; 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
 
 
 
 Job Function
 
 
 
 Legal &amp; Compliance
 
 
 
 Job Sub Function
 
 
 
 Health Care Compliance
 
 
 
 Job Category
 
 
 
 People Leader
 
 
 
 All Job Posting Locations:
 
 
 
 Cairo, Egypt
 
 
 
 Job Description
 
 
 
 
 Health Care Compliance Officer, Innovative Medicines
 
 
 
 Area:
 
 JENA
 
 
 cluster
 
 
 
 Location:
 
 Cairo, Egypt
 
 
 
 Contract: Full Time, Hybrid
 
 
 
 Overall Purpose Of This Role
 
 
 
 Serves as a
 
 Health Care Compliance Officer (HCCO) for the Innovative Meducine JENA cluster
 
 . Leads and drives the Health Care Compliance (HCC) program to ensure business practices and activities are in compliance with related J&amp;J internal guidelines, local laws and regulations and anti corruption laws including the Foreign Corrupt Practices Act. Serves as a strategic business partner for management and coach towards all covered employees, to assure that the company culture of compliance is a natural element in day to day business. Position is located in Cairo, Egypt.
 
 
 <ul>
 <li>
 This position reports to the HCCO Emerging Markets and dotted line to the JENA IM Managing Director
 
 
 </li>
 </ul>
 
 ESSENTIAL DUTIES AND RESPONSIBILITIES
 
 include the following. Other duties may be assigned.
 
 
 <li>
 Partner with company executive leadership to ensure that the HCC program effectively prevents and/or detects violations of law, regulations, policies, or the Code of Conduct by:
 </li>
 <ul>
 <li>
 Establishing &amp; chairing the local Compliance Committee of JENA, the committee responsible for designing and implementing an effective compliance program and key decision making
 </li>
 <li>
 Translating global HCC strategies into cluster/country level strategy based on appropriate cluster needs, goals and objectives, taking into account local external regulatory trends and environment
 </li>
 <li>
 Assuring adequate representation in relevant business governance structures and establish discussion platforms to get general business buy-in and impact analysis
 </li>
 <li>
 Stimulating and contributing to innovative approaches towards HCPs and GOs consistent with the HCC/HCBI guidelines and framework and performing business plan reviews
 </li>
 <li>
 Working with the J&amp;J Office of Compliance, Government Affairs, Regulatory, Legal, and external organisations (primarily trade associations) to shape &amp; influence the environment and industry codes of conduct
 </li>
 <li>
 Providing and coordinating appropriate guidance, education, training, and regular communications on HCC to all covered employees, including Affiliate/Managing Director, Management Board, etc.
 </li>
 <li>
 Conducting self-assessment and risk assessment processes to detect process gaps &amp; inconsistencies
 </li>
 <li>
 Developing a testing &amp; monitoring plan to demonstrate that the HCC program is effective and participate in execution where appropriate and engage Affiliate/ Board participation in roll out
 </li>
 <li>
 Coordinating preparations for Corporate Internal Audits
 </li>
 <li>
 Coordinate the establishment of the Management Action Plan, and guide the business partners to close gaps and implement corrective actions
 </li>
 <li>
 Managing day-to-day allegations and investigations
 </li>
 <li>
 Participating in and leading investigations of non-compliance and implementing the escalation process for serious allegations, as appropriate
 </li>
 <li>
 Communicating on status of the HCC program regularly to the line manager and the relevant board(s)
 </li>
 <li>
 Partnering with the Global/Regional Operations team
 </li>
 <li>
 Interface with legal counsel regarding HCC and Privacy requirements and interpretation
 
 
 </li>
 </ul>
 
 Direct Reports
 
 
 
 <ul>
 <li>
 Senior HCC Specialist - JENA
 
 
 </li>
 </ul>
 
 We Would Like If You Do Have
 
 
 
 BA/BS, advanced degree or equivalent preferred and a minimum of 3 years business experience.
 
 
 Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, or Regulatory Prior experience in project management is required.
 
 
 Good command of English and Arabic.
 
 
 Experience in Health Care Compliance would be valued.
 
 
 Understands and masters the J&amp;J Credo based culture.
 
 
 Knowledge of laws, regulations and industry standards for the countries is a plus.
 
 
 
 OTHER SKILLS And ABILITIES
 
 
 
 <ul>
 <li>
 Requires strong communication, organization and analytical skills
 </li>
 <li>
 Ability to influence business decisions and business partners
 </li>
 <li>
 Ability to take complex business situations and develop solutions to ensure compliant growth is achieved
 </li>
 <li>
 Ability to combine sector orientation with cross sector goals and objectives
 </li>
 <li>
 Proven track record in delivering results, self starter
 </li>
 <li>
 Committed team player
 </li>
 </ul>
</div>

Health Care Compliance Officer, Innovative Medicine

Explore 266+ Regulatory affairs specialist in Cairo this September. Find roles across top companies and apply now to boost your career.

266 regulatory affairs specialist jobs IN Cairo

Regulatory Affairs & Clinical Operations Assistant (Contractor)

Regulatory and Wellbeing Affairs Assistant Manager

Regulatory Coordinator

Logistics Coordinator (1 year contract)

DRA Senior Associate, Gulf

Health Care Compliance Officer, Innovative Medicine

Health Care Compliance Officer, Innovative Medicine