Regulatory Affairs and Labelling Associate

Aspen Pharma Group


Date: 21 hours ago
City: Dubai
Contract type: Full time
ROLE PURPOSE:

  • Execute regulatory affairs activities to meet departmental and business goals while ensuring compliance with health authority regulations in assigned markets.
  • Ensure alignment with the company’s internal procedures for regulatory standards.
  • Define, determine, and communicate regulatory requirements and due diligence to stakeholders and project teams.
  • Collaborate with cross-functional teams to manage the entire process from concept/development to artwork release for regulatory artwork changes.

REGULATORY & LABELLING RESPONSIBILITIES:

Regulatory Documents Submission:

  • Compile and submit regulatory documents (new registrations, variations, etc.) according to local requirements.
  • Ensure timely follow-up on submissions and manage timely deficiency responses.
  • Prioritize high-margin products aligned with business objectives.

Regulatory Tracking:

  • Update regulatory trackers with accurate information and provide input for regulatory plans.

Documents Archiving:

  • Archive submitted dossiers (soft copies) in shared folders and Veeva RIMs as applicable.

Regulatory Guidelines Support:

  • Develop a detailed understanding of regulatory guidelines and technical requirements for assigned countries.

Regulatory Plans Execution:

  • Collaborate with the regulatory manager to develop and implement regulatory plans for complex projects (e.g., product transfers, life cycle maintenance, etc).

Renewals Management:

  • Manage product and site renewals for the assigned markets by adhering to submission deadlines in the renewal tracker.

Cross Functional Support:

  • Provide solutions to a variety of problems of moderate scope of complexity. Interacts with internal and/or external stakeholders. Identifies and responds appropriately to issues, providing adequate solutions.
  • Work cross functionally on new products launches and products acquisition. Build better and stronger relationships with relevant internal and external stakeholders

Labelling & Artwork Management (Local/Global IPs):

  • AW word files development, annotation and review of the artworks in compliance with local labelling guidelines ensuring quality control English version as well as the Arabic translation to have robust texts.
  • Mock-ups creation to support various types of submissions (on Pulse system or with 3rd parties).
  • Artwork release post MOH approval and ensures all relevant stakeholders are informed as needed (on Pulse system or with 3rd parties).
  • Maintain AW tracker and archives for all the ongoing changes for the artworks.

Compliance:

  • Ensure adherence to the company’s SOPs and work instructions.

RA Team Support:

  • Work on assigned projects to assist other team members where needed based on the business priorities

Regulatory Guidelines Monitoring:

  • Monitor changes in the healthcare regulatory environment and communicate updates to relevant stakeholders for implementation.

POSITION REQUIREMENTS:

Level of Education required:

  • Bachelor’s degree - In Pharmaceutical Sciences or a relevant life science degree - required
  • Master’s Degree - Added value
  • MOH Pharmacist License - Added value

Years of experience required:

  • 2-4 years’ experience in Regulatory affairs (FMCG/Nutrition/Pharma/consumer)

Technical skills:

  • English writing & speaking - Advanced
  • Arabic - Added value
  • French - Added value
  • Good working knowledge of MS Office (Word, Excel & Power Point) - Intermediate to Advanced
  • Analytical thinking skills - Good
  • Understanding of the local regulations - Very Good
  • Time Management - Very Good

Aspen Competencies:

BUSINESS:

  • Problem solving & Good judgment
  • Makes Good Decision

PEOPLE:

  • Communicate Effectively
  • Dealing with ambiguity/Embrace change

SELF:

  • Takes action with Integrity, Contribute Special Expertise
  • Continuously grows and develops

Soft Skills:

  • Honesty & Ethical Conduct
  • Perseverance and tenacity
  • Flexibility and tolerance for ambiguity
  • Planning and organizational skills
  • Empathy
  • Responsibility and accountability
  • Information seeking
  • Writing skills
  • Capacity for and resistance to stress
  • Active listening skills
  • Results Oriented
  • Curiosity/learning agility
  • Focused
  • Initiative taking

#AT

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Spa Host

The Lana, Dubai - Dorchester Collection, Dubai
13 hours ago
HotelThe Lana - Dorchester CollectionDivision & DepartmentRooms - SpaJob TitleSpa HostContract TypePermanentStatusFull timePosition OverviewWe are not just a collection of hotels, but instead a talented community. A family with a shared passion and commitment to, unapologetically, love and breathe who we are every day. An eclectic grouping who really care about each other and our guests, where belonging transcends all...

Maintenance Planner - DWC

dnata, Dubai
14 hours ago
Job PurposeAs a Maintenance Planner, you will be responsible for planning, scheduling and coordination of all plannable maintenance work performed by the maintenance team.Your Duties Will Include But Not Limited To Plans, schedules, allocates and coordinates all jobs undertaken by the maintenance team while ensuring optimum resource utilisation. Anticipates and mitigates potential delays through the proactive planning and coordination of...

Travel Consultant - Meetings & Events

dnata, Dubai
15 hours ago
Job PurposeThe jobholder is a front-line staff member and a part of a team who has to provide clients and potential clients superior and a consistent quality of travel services. To sell Airline tickets, travel related products and give travel related information. Proactively service our customers via various channels (retail, phone, WhatsApp, email), supporting them with queries, amendments, pro-active disruption...