Manager, Regulatory Affairs Europe, General Medicine - United Kingdom
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- We have an exciting opportunity for a Manager, Regulatory Affairs Europe, General Medicine to join our team.
- The person in this role, will report to the Director, Regulatory Affairs based in Brussels and coordinate regulatory activities in the EEA, Switzerland and non-EU CES countries. Strategies for products in development and registered products will be implemented in collaboration with the team members.
- Our General Medicine portfolio entails new registration and maintenance products in Neuroscience, Womens’ Health, Respiratory, Dermatology, Immunology, Bone, Cardiovascular and Diabetes.
- Responsible for coordinating the preparation, review and submission of regulatory dossiers in support of post-approval submissions in the EEA, Switzerland and non-EU CES countries.
- Handle new product registrations in collaboration with the Regulatory Affairs Director, EU for the assigned products.
- Manage submissions and interactions with the EU regulatory agencies.
- Liaise directly with Merck Headquarters and US-based cross-functional teams to communicate regional requirements and ensure compliance with all the required regulations for assigned projects.
- Manage centralized procedures, working in conjunction with regional subsidiary staff for decentralized procedures and provide critical assistance for national submissions in the above-mentioned region.
- Work with project teams to develop and implement regulatory strategies (including scientific advises and pediatric investigational plans, or orphan designation), identify regulatory risks, and enable earliest possible approval.
- Ensure regulatory strategies are aligned with project teams and business objectives and deliverables.
- Ensures regulatory milestones for assigned projects are met.
- Maintenance of a sound scientific knowledge and expertise for all assigned product areas.
- Stay abreast on changes in the EU environment which could affect the company regulatory strategy.
- Serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams.
- Coordinate or oversee preparation of regulatory documentation in a timely manner to meet corporate objectives.
- Develop and implement effective processes to meet business objectives and ensure appropriate compliance with regulatory requirements
MSc. in Pharmacy or Chemistry or equivalent Life Science degree is required.
Experience and knowledge Required:
- Minimum 2 years of experience in the pharmaceutical industry within Regulatory Affairs .
- Knowledge of EU regulations, guidelines and regulatory processes for product life cycle maintenance.
- Fluent written and spoken English.
- Strong organization and planning skills.
- Ability to manage multiple projects with changing priorities.
- Ability to work in cross-functional and international environment.
- Detail- and goal-oriented, quality conscientious, and customer focused.
- Ability to adhere to strict project timelines, strong team player.
- Problem solving skills, with ability to identify,analyze, and resolve problems in a timely manner.
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Travel: Yes, 10 % of the Time
Number of Openings: 1
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