Regulatory Affairs Manager

2 weeks ago

Dubai, United Arab Emirates Biogen Full time

The incumbent will work in close collaboration with GCC Regulatory and commercial organizations, as well as relevant local stakeholders.

This role reports directly into the Head of Regulatory Affairs - GCC Cluster.

**Registration Planning**
- Work according to the strategic directions defined by the Head of Regulatory Affairs - GCC and in line with GCC commercial organization objectives,
- Responsible for development and execution of registration strategy and plans for product(s) under his/her responsibility in line with the regional regulatory strategy, business plans and objectives (including expected submission & approval timelines)
- Responsible for providing inputs of anticipated market specific regulatory issues for planned submissions, local strategic guidance, insights, interpretation, advice and updates related to GCC markets based on the local laws, requirements and market practice.

**Dossier preparation, submission and product Approval**
- Works closely with the Regulatory and cross functional teams and other internal and external stakeholders, as necessary
- Accountable for leading country regulatory submission activities for new products & life-cycle management activities for the registered products.
- Executes the agreed plans by coordinating dossier submission within agreed timelines and obtains Drug Regulatory Agencies approvals for new chemical entities (NCEs) as well as post-registration variations.
- Ensure submitted product documents fully meet the local regulatory requirements for GCC markets.
- Follow-up with the local distributor and regulatory authorities during submission, file review and ensure all questions /requests are provided/clarified/addressed within due time to ensure timely approval of the products.
- Support achieving product pricing for new products as per agreed plan.
- Ensure proper communication/archiving of all documents submitted to the local Health Authorities as required.
- Ensure consistent and transparent communication of regulatory timelines, changes to timelines to Head of regulatory GCC and business partners.

**Regulatory Compliance**
- Raises awareness and advising impact of developing lifecycle asset activities to the Head of Regulatory GCC.
- Maintains products license and ensure all marketed products in the country are in compliance with local and corporate regulatory requirements, i.e. labeling (Product Information and packaging development); label change management; Chemistry, Manufacturing and Control commitments submitted to the local Health Authorities.
- Initiates, manages and oversees the labelling and artworks development process (review, approval, implementation) within agreed timelines and local Health Authorities regulations.
- Review English labels and its Arabic translation and follow up with external supplier on proposed changes implementation.
- Tracking of regulatory commitments
- Manages local regulatory interactions with Health authorities to support product recall when necessary.
- Ensures all regulatory activities are performed in line with local regulations.
- Review promotional materials and ensure content is in line with local regulations, corporates SoPs and regional code of practice.

**Regulatory intelligence**
- Ensures contemporary contribution to Regulatory Intelligence/Interpretation and Experience
- Understand the local regulatory guidelines and requirements for the countries under her/his responsibility and effectively communicate to the regulatory and business colleagues in a timely manner any change in the regulation that could have impact on the products portfolio and/or operations.
- Provides Competition intelligence and/or interpretation of business impact to local stakeholders as required.
- Liaison and relationship building and information sharing with GCC Regulatory team.

**Regulatory Influence**
- Establishes and maintains regular, strong and trustworthy relationship with regulatory officials.
- Communicates with the local distributor to ensure optimized and compliant regulatory procedures.
- Maintains contact and liaises when needed with key business partners, internally and externally.

**Qualifications**
- A minimum 8-10 years’ experience in Regulatory Affairs in GCC region.
- Demonstrated strategic regional regulatory thinking and risk assessment capability.
- Broad knowledge of GCC countries pharmaceutical legislation.
- Proven track records of fast-track registration in GCC. Good experience in interfacing with relevant regulatory authorities.
- Effective and positive interactions with regulatory agencies, and external partners.
- Ability to assimilate new knowledge rapidly and deep understanding of cross functional drug development process and high scientific/clinical knowledge across key therapeutic areas to enable position holder to discuss compound.
- Good Analytical skills, accuracy and reliability.
- Demonstrated capability of strategic regional regulatory thinking and risk assessment

**Additiona

  • Associate Manager Regulatory Affairs | Dubai

    2 months ago

    dubai, United Arab Emirates Associate Manager Regulatory Affairs Full time

    Associate Manager Regulatory Affairs | DubaiWe are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.Works autonomously, but in alignment with MEA Regional Director of Regulatory Affairs & Scientific Office, to oversee day-to-day Regulatory...

  • Associate Manager Regulatory Affairs | Dubai

    2 weeks ago

    dubai, United Arab Emirates Associate Manager Regulatory Affairs Full time

    Associate Manager Regulatory Affairs | DubaiWe are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.Works autonomously, but in alignment with MEA Regional Director of Regulatory Affairs & Scientific Office, to oversee day-to-day Regulatory...

  • Regulatory Affairs Manager

    2 months ago

    dubai, United Arab Emirates Abu Dhabi Islamic Bank PJSC Full time

    Role Purpose:The Regulatory Affairs Manager is responsible for providing Regulatory Advisory to Business unit, management of Regulatory Affairs Unit framework and support in the day-to-day management of ADIB Ethical Conduct framework.The Regulatory Affairs Manager shall also support in maintaining a positive relationship with regulatory authorities and to...

  • Regulatory Affairs Manager

    2 weeks ago

    dubai, United Arab Emirates Abu Dhabi Islamic Bank PJSC Full time

    Role Purpose:The Regulatory Affairs Manager is responsible for providing Regulatory Advisory to Business unit, management of Regulatory Affairs Unit framework and support in the day-to-day management of ADIB Ethical Conduct framework.The Regulatory Affairs Manager shall also support in maintaining a positive relationship with regulatory authorities and to...

  • Regulatory Affairs Manager

    7 days ago

    Dubai, United Arab Emirates AstraZeneca Full time

    **JOB TITLE** **Regulatory Affairs Manager** **ABOUT ASTRAZENECA** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical...

  • Regulatory Affairs Manager

    5 days ago

    Dubai, United Arab Emirates Pfizer Full time

    Why Patients Need You The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to facilitate the best patient care. Our patients need dedicated...

  • Regulatory Affairs Manager

    2 weeks ago

    Dubai, United Arab Emirates Astellas Full time

    Algemene informatie Job Advert Title Regulatory Affairs Manager - Gulf Locatie Dubai Function/Business Area Regulatory Affairs Afdeling MENASSA Regulatory Affairs Werkcategorie Arbeidsovereenkomst voor onbepaalde tijd Functiebeschrijving Regulatory Affairs Manager - Gulf **About Astellas**: At Astellas we can offer an inspiring place to work and...

  • Associate Manager Regulatory Affairs

    2 months ago

    Dubai, United Arab Emirates Ipsen Pharma (SAS) Full time

    **Job Description Summary*** Supports MEA Regional Director of Regulatory Affairs & Scientific Office. Ensure product regulatory compliance with applicable regulations and standards in MEA. **Main** **responsibilities** **/** **job** **expectations** Works autonomously, but in alignment with MEA Regional Director of Regulatory Affairs & Scientific...

  • Regulatory Affairs Manager

    1 month ago

    Dubai, United Arab Emirates ZainTech Full time

    The Regulatory Affairs Manager works closely with the Head of Department to monitor the company’s activities and ensures compliance with applicable regulations and standard operating procedures within the countries of operation. The Regulatory Affairs Manager is responsible for overseeing licensing, driving legal studies, opinions, and consultancies,...

  • Regulatory Affairs Executive

    2 months ago

    Dubai, United Arab Emirates TheSay Pharma General Trading Full time

    **Regulatory Affairs Executive immediate Joining.** **Requirements**: Post graduate in pharmacy or life sciences with at least 3 years experience in medical device regulatory affairs, Regulatory Affairs 3-4 Years of experience in UAE Registrations, Must have knowledge about dossiers and Handling of e-CTD software. Exposure to DMF preparation, regulatory...

  • Regulatory Affairs Executive

    2 months ago

    Dubai, United Arab Emirates Robustrade DMCC Full time

    **Scientific Office Pharmacist - Regulatory Affairs Executive** You will be responsible for the regulatory affairs function for an assigned territory of the UAE & GCC region. **Relevant skills, Experience & Knowledge**: Experienced in Conventional Medicines with eCTD submissions, GSL, Herbal, Medical Devices Pharmaceutical Products in MOHAP. The primary...

  • Regulatory Affairs Intern

    2 weeks ago

    Dubai, United Arab Emirates Boehringer Ingelheim Full time

    **Regulatory Affairs Intern** **-** **231227** **OUR COMPANY** At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative...

  • Regulatory Affairs Manager

    7 days ago

    dubai, United Arab Emirates Biogen, Inc. Full time

    The incumbent will work in close collaboration with GCC Regulatory and commercial organizations, as well as relevant local stakeholders.He/she will lead regulatory activities for the assigned portfolio to ensure submissions and approval of new marketing authorization applications (MAAs) and post-registration variations within the agreed timelines.This role...

  • Regulatory Affairs Manager

    7 days ago

    Dubai, United Arab Emirates Givaudan Full time

    Step into our world of creativity and joy! Regulatory Affairs Manager - Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with passion and creativity, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There’s much to learn and many to...

  • Regulatory and Scientific Affairs Manager

    2 weeks ago

    Dubai, United Arab Emirates Nestle Full time

    **POSITION SNAPSHOT** - Location: Dubai - UAE - Company: Nestlé - Role: Regulatory and Scientific Affair Manager *** An exciting opportunity has arisen for a Regulatory Affairs Manager to join our business, this is a varied role that will works across the MENA region. In this role you will be responsible for ensuring the compliance of all local and...

  • Regulatory Affairs Expert

    7 days ago

    Dubai, United Arab Emirates Kinetic Full time

    A leading Medical Devices company is actively recruiting for a **Regulatory Affairs Expert** to be based in **Dubai, UAE.** *** **Applicants must have a Valid Ministry of Health License.** **The main responsibilities will include**: - Ensuring compliance with regulations. - Defining and executing regulatory plans and managing timelines to achieve the...

  • Regulatory Affairs Officer

    3 days ago

    Dubai, United Arab Emirates Nathan & Nathan Human Resources Full time

    We are hiring a Regulatory Affairs Officer for a Pharmaceutical industry client to join their team in Dubai. RESPONSIBILITIES Responsible for coordinating and preparing CTD/eCTD submission package in accordance with regulatory requirements, and ensuring that submission is complete, accurate, and submitted on time Responding to regulatory queries and...

  • Executive - Regulatory Affairs

    3 days ago

    Dubai, United Arab Emirates STERLING PERFUMES INDUSTRIES Full time

    Responsible for ensuring regulatory compliance related activity for perfume products. You will supporting quality manager to complete full activity relating to Regulatory Affairs. **Job Types**: Full-time, Permanent **Salary**: AED2,500.00 - AED3,000.00 per month Application Deadline: 09/03/2024

  • Regulatory Affairs Officer

    1 week ago

    Dubai, United Arab Emirates Nazih Group Full time

    **As a regulatory affairs officer you'll be the crucial link between company, its products and regulatory authorities. You'll combine your knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a range of company, meet the required legislation.** **Job Summary**: The Regulatory Officer -...

  • Regulatory Affairs Manager

    2 months ago

    Dubai, United Arab Emirates Abbott Laboratories Full time

    **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full...