Are you looking for an opportunity to develop regulatory strategies in line with business goals?
Do you possess a strategic regulatory mindset with the ability to calculate risk?
Are you located in North Rhine-Westphalia, Germany, or are you willing to relocate?
Fraser Dove International is working exclusively with an innovative organisation specialising in developing ground-breaking medicines to treat a variety of diseases and illnesses. Operating worldwide, they are committed to adding value and improving their patient’s quality of life.
Our client is seeking an experienced individual act as the interface between Global Regulatory Affairs and national health authorities.
Discover more about our Project Leader Regulatory Affairs opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Project Leader Regulatory Affairs, you will be measured against the following objectives:
1) Taking responsibility for national registration applications and activities within the EU.
2) Managing generation and life-cycle management of national product dossiers.
3) Acting as a reliable contact partner for local health authorities, associations, and further external Regulatory Affairs (RA) contact points.
What you will do:
As the Project Leader Regulatory Affairs, your duties and responsibilities will include:
- Acting as the interface between Global Regulatory Affairs and national health authorities.
- Developing regulatory strategies to enable optimised product launches in Germany that are in line with the business plan.
- Owning responsibility for the creation and lifecycle management of national product dossiers.
- Ensuring compliance with local regulatory compliance requirements in accordance with corresponding Standard Operating Procedures (SOPs).
- Serving as a Subject Matter Expert in RA and advising other departments e.g. Marketing.
- Developing and evaluating scientific texts in cooperation with the medical department on site.
- Overseeing the timely update of internal and external databases, and document management systems.
- Managing regulatory lifecycle and regulatory database of assigned products.
- Serving as the reliable contact person for local authorities, associations, and other external RA contact points.
What you will bring:
These are the skills and experience you will need to succeed as the Project Leader Regulatory Affairs:
- First-rate stakeholder engagement and management skills.
- Ability to define pro’s and con’s for alternate approaches and make effective decisions based on this analytical data.
- Self-motivated and able to deal with new or difficult decisions easily.
- Excellent communication skills and the ability to speak both German and English fluently.
- Confident decision-maker and the ability to think strategically.
- Strong expertise with German regulatory activities.
- Doctorate or master’s degree in a scientific field (e.g. pharmacy, biology, or chemistry).
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Generous annual bonus.
- Car/travel allowance.
- Generous holiday allowance.
Got what it takes?
To apply for the Project Leader Regulatory Affairs, click the ‘Apply’ button below or contact the Executive Search Consultant – Dan Eastwood – on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.