Regulatory Affairs Specialist - Gulf Levant

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

REGULATORY AFFAIRS

Advance Pipeline/Marketed Product Support: Submissions, Renewals & Approvals:

• Prepare registration files as per each country specific requirements and make sure to meet the planned submission/approval dates by working closely with Area Regulatory team, as well as the local distributors and MOHs in all countries.
• Gather a thorough knowledge of the registration files of assigned company product documentation. Keep up to date on assigned products
• Work with the demand and marketing departments for proper Business Case Form preparation.
• Ensure that all Regulatory submissions (new marketing authorisation applications, renewals, variations, notifications) are prepared and filed in a timely manner for assigned Company products marketed and/or registered in Levant Region or new products intended to be marketed in Levant  Region. Follow up all steps for authorisation/approval of these submissions.
• Gain Regulatory Authority approval for marketing authorisations for new products.
• Maintain all existing product marketing authorisations and gain Regulatory Authority approval of variations (amendments) to these authorisations as required.
• Manage any further information requests from local Regulatory Authority in a timely manner, ensuring local authority’s expectations are accurately translated for AbbVie Area Regulatory. Submission of any subsequent responses/product documentation updates to local Regulatory Authority.
• Review Product Information in accordance with legal and regulatory requirements; ensure that all prescribing information is accurate, updated and approved by both Company and relevant Regulatory Authority in accordance with Company policies and local regulations.
• Review promotional materials per the approved labeling, applicable guidelines and local regulations, and within the required timeframe
• Work closely with logistics department to organize timely sample delivery
• Coordinate with Labeling specialist regarding implementation within agreed timeframe, including development with third parties of updated artwork for cartons, labels and leaflets in accordance with Company requirements and local regulations for all products.
• Co-ordinate handling of company core date sheet (CCDS) updates for assigned products.
• Management of periodic safety update reports (PSURs) for products of the portfolio.
• Provide feedback and support on regulatory strategy and status on regular basis.
• Keep abreast of emerging legislation, local or international, related to registration and pharmacovigilance and highlight the potential impact on the business.
• Support medical department with clinical trial requirements

Regulatory Excellence:

• Cooperate and liaise with manufacturing sites, corporate head-office and other Levant Region departments.
• Represent AbbVie in the relevant pharmaceutical trade associations and liaise with external stakeholders, as appropriate.
• Establish and maintain good relationship with all involved regulatory institutions in Levant Region.
• Identify and track changes/trends in the authorisation practice and attitudes in Levant Region and communicate them within the Company.
• Coordinate and ensure effectiveness of Regulatory Affairs function.
• Support NPI/Launch Excellence process in Levant

Compliance/Training:

• Ensure compliance with AbbVie’s corporate policies, procedures and guidelines as well as with local regulations to meet statutory, quality and business requirements within the overall strategy and objectives of the Gulf and Levant Region.
• Be the support function within Levant Region for Regulatory training and other Regulatory-related activities.

Transforming the Organisation: FutureFit/LRP:

• Participate in local brand teams to assist with product development and project planning to ensure that the proposed development plans account for regulatory requirements and that clinical advice is available throughout the process.
• Support business development on the market.
• Coordinate activities that assist product areas by providing support to all required functions

• A Bachelor's degree in a medical or health-related field, such as Pharmacy, Biomedical Sciences, or similar disciplines, with a strong foundation in scientific knowledge and healthcare principles. 
• proven track record of 3-5 years of professional experience within a multinational organization, demonstrating the ability to work effectively in diverse and dynamic environments.
• Previous Experience in a regulatory position in healthcare industry in clinical trials
• Fluency in English both verbal and written, efficient Computer Skills.
• Team player with ability to work to tight deadlines
• Thorough attention to details and high standards of accuracy
• Significant knowledge of Local (and global (EU and US)) Regulatory Affairs requirements.
• Sound judgment, strong communication and negotiating skills

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html