Pharmaceutical Regulatory Affairs Manager

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We are looking for an experienced and knowledgeable Pharmaceutical Regulatory Affairs Manager, for our client, an important company in the pharmaceutical production field.

- Deep experience in pharmaceutical industry from a regulatory affairs perspective – min. 5 years in a similar position
- Bachelor’s degree in biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology or medicine
- Strong Knowledge of Romanian and European pharmaceutical legislation, relevant guidelines, procedures and requirements
- Excellent written and spoken English language
- Outstanding communication and interpersonal skills
- Strong planning and project management abilities
- People management skills

- Managing the activities of Regulatory Affairs ensuring the implementation of appropriate and effective regulatory strategies;
- Ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements;
- Providing expert regulatory input to strategic decision making;
- Overseeing the planning, coordination, and management of regulatory documentation activities;
- Ensuring that quality standards are met and that the deliverables meet strict deadlines and fulfil Romanian and European regulatory and quality standards;
- Developing regulatory strategies and implementation plans for new products;
- Formulating or implementing regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced;
- Maintaining contact with the National Medicines Agency (NAMMD), National Research and Development Institute for Food Bioresources, the Ministry of Health;
- Keep up-to-date with changes in regulatory legislation and guidelines developed by the National Medicines Agency, the Ministry of Health (food supplements), National Research and Development Institute for Food Bioresources (food supplements) and medical devices on the activity of Regulatory Affairs;
- Implement different strategies in order to meet evolving regulatory initiatives;
- Managing subordinate staff in the day-to-day performance of their jobs.

Benefits:
- Motivational salary package
- Private Medical Insurance
- Company car
- Meal tickets
- A dynamic work environment with a culture that is open, innovative and performance-orientated