Regulatory Affairs Specialist

At Hikma we put better health within reach, every day in more than 50 countries around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more info Disclaimer: EMPLOYMENT RECRUITMENT FRAUD ALERT Please be advised that the Hikma Pharmaceuticals Group does not ask its employees or prospective employees to wire any money either to its bank accounts or to any third party, and does not conduct employment interviews via any social media platform, Google Hangouts, Yahoo! Messenger, text message, or e-mail. Unfortunately, employment scams are increasingly common and it is important to remain vigilant when conducting a job search. For more information about these scams, see the UK National Fraud Intelligence Bureau’s website and the US Better Business Bureau’s article on the subject. If you receive a request to send money through any means or a request for personal information from anyone claiming to be a Hikma recruiter, DO NOT REPLY. Instead, please forward the communication(s) to us at [email protected] so that we may provide it to relevant law enforcement agencies, as appropriate.

Website

http://www.hikma.com Job Purpose:

Regulatory Affairs Specialist is responsible for performing Regulatory activities to maintain product registrations, product licenses and relevant life cycle management activities within the defined timelines and in full compliance with the legislations and regulations.

Duties & Responsibilities

• Obtain marketing authorizations and appropriate legal approvals.
• Maintain licenses for existing products.
• Prepare submission documents for new product registrations, renewals, and variations.
• Preparation of responses to requests by the Authority during the evaluation process, and timely handling of deficiency letters within the specific timeframe.
• Maintain a full up-to-date database and archiving system for tracking Regulatory dossiers.
• Ensure effective communication with the Regulatory Authority.
• Ensure company compliance with regulatory regulations.
• Follow up and implement any updates on the regulatory regulations and guidelines, keeping all relevant stakeholders timely and pro-actively updated.
• Effective communication and cross-functional interaction with all involved departments, both on a Regional and Central level (Regulatory Affairs, Quality Assurance, Quality Control, Production, Supply chain, Sales and Marketing and Pharmacovigilance) to facilitate and develop effective collaboration on all regulatory interactions.
  
  

Qualifications

• Bachelor’s degree in pharmacy.
• At least 3-5 years professional experience in Regulatory Affairs.
• Good understanding of Regulations.
• Knowledge of the structure and the specifics of formation and functioning of the dossier in CTD/eCTD formats.
• High English proficiency.
• High organizational and communication skills