Regulatory Affairs Executive

Boehringer Ingelheim View all jobs

  • Dubai
  • Permanent
  • Full-time
  • 6 days ago
We are IMETAROPU IMETA is a Regional Operating Unit consisting of 6 mid-sized Operating Units: India, Turkey, Southern Africa (South Africa & Sub Sahara Africa) Northeast & West Africa, Near East & UAE, Saudi Arabia, Gulf & East Africa (SAGEA).IMETA is home to more than 47 nationalities. We are a myriad of color and culture and embracing this diversity is one of our greatest opportunities.We are a powerhouse of talent, and we work together to ensure that we grow, nurture, and retain our talent. Uniting and working together is the key to our success.The Position:We are looking to hire a Regulatory Affairs Executive who will contribute to regulatory affairs by ensuring compliance and smooth product lifecycle management. The position involves preparing and submitting new product registration dossiers, managing variation applications and post-approval commitments. Will act as the primary regulatory contact for local partners and Health Authorities, collaborate cross-functionally with internal teams, and monitor regulatory trends to mitigate risks effectively.This role will report to Head of Regulatory Affairs.Responsibilities:
  • Prepare, compile, and submit product registration dossiers (CTD/eCTD) for new products, line extensions, renewals, and variations (administrative, quality, and safety changes) in alignment with local and global regulatory requirements.
  • Manage post-approval commitments, ensuring timely updates to Health Authorities (HAs), renewal of marketing authorizations, and maintenance of valid product licenses to avoid compliance issues.
  • Review and update artworks, labeling, and leaflets in compliance with regulatory guidelines, ensuring accuracy and adherence to local regulations, global SOPs, and internal quality systems.
  • Act as the primary regulatory contact for Health Authorities in assigned countries, handling queries, deficiency letters, and regulatory clarifications in a timely and accurate manner while supporting regulatory meetings, negotiations, and consultations.
  • Work closely with Medical, Quality, Supply Chain, Commercial, and Global Regulatory Affairs teams to ensure smooth regulatory operations, provide input for launch planning, product lifecycle management, tenders, and pricing activities.
  • Monitor and interpret new regulatory guidelines, policy updates, and trends across regions, evaluate potential regulatory risks, and propose clear, actionable mitigation strategies to minimize impact on operations.
  • Maintain accurate and updated regulatory archives, submission records, product databases, and dashboards while supporting pharmacovigilance regulatory requirements (RMP submissions, PSURs, and safety variations).
Requirements:
  • Bachelor's degree in pharmacy
  • Minimum 2-4 years of experience in Regulatory Affairs within multinational pharmaceutical company.
  • Experience interacting with Health Authorities, including dossier submission, responses to queries, and regulatory negotiations.
  • Excellent understanding of GCC and Middle East regulatory frameworks alongside pharmacovigilance regulatory requirements (PSURs, RMPs, variations related to safety).
  • Strong knowledge of product registrations, renewals, variations, and life-cycle management.
  • Previous experience in compiling and reviewing CTDs/eCTDs, artwork, labeling files.
  • Fluency in Arabic and English is a must (written and spoken).
Skills & Competencies
  • Ability to work with multiple digital systems and platforms as part of daily responsibilities
  • Negotiation skills with the ability to influence regulatory outcomes and manage complex discussions.
  • Analytical mindset, capable of assessing regulatory impacts, identifying risks, and proposing mitigation plans.
  • Ability to coordinate cross-functionally with Medical, Quality, Supply, Marketing, and Global RA teams.
  • Ability to prioritize multiple tasks and meet regulatory deadlines.
  • High attention to detail and strong documentation/archiving abilities.
  • Ability to work independently, with problem-solving and decision-making capability.
What happens Next?We are looking forward to receiving your application! We will then have a look at your CV. If we see a match, we will invite you for a screening interview.SPL Screening:In order to comply with applicable export control laws, Boehringer Ingelheim periodically screens business relations (including job applicants) against sanctioned party lists (“SPL”). These checks may be performed by Boehringer Ingelheim or by any of its Affiliates. You acknowledge that Boehringer Ingelheim and/or its Affiliates will screen you against SPL and that for this purpose your personal data may be processed in relevant databases, including databases of third-party vendors that perform SPL screening for or on behalf of Boehringer Ingelheim or its Affiliates which may be located or accessible outside the EU. Boehringer Ingelheim is committed to ensuring an adequate level of protection of your personal data.

Boehringer Ingelheim