Do you have at least 5 years of experience in global regulatory affairs in late-stage drug development?
Are you looking for an opportunity to put all your experience to good use as a subject matter expert for a global pharmaceutical organisation?
Are you located in Munich, Germany, or are you willing to relocate?
Fraser Dove International is partnering exclusively with a pharmaceutical organisation, specialising in creating and supply innovative pharmaceutical products. Operating worldwide, our client is committed to saving lives.
Our client is seeking a regulatory affairs specialist to set standards and provide regulatory affairs expertise in a growing organisation.
Discover more about our Senior Manager Regulatory Affairs Oncology opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Regulatory Affairs Senior Manager (Oncology), you will be measured against the following objectives:
1) Ensuring the safety and operational standards within the pharmacovigilance department are maintained and fulfilled.
2) Providing expertise on regulatory matters on a collaborative basis in both Europe and globally.
3) Acting as a specialist in oncology and representing RA in external interactions.
What you will do:
As the Regulatory Affairs Senior Manager (Oncology), your duties and responsibilities will include:
- Representing RA in external interactions (e.g. authorities, affiliates, partners, CROs).
- Providing expertise on the regulatory strategy to achieve regional and global goals.
- Offering European regulatory strategy support for assigned projects, covering product development plans, clinical trials and product life cycle management.
- Providing regulatory guidance and strategy, and supporting EU Marketing Authorisations Applications (MAA) submissions.
- Acting as the representative of European Regulatory Affairs on global development teams.
- Acting as the regulatory contact person to authorities for assigned projects.
- Participating in assigned non-project tasks and process improvements.
- Keeping up-to-date with regulatory and scientific regulations, directives, guidelines and initiatives.
- Communicating important regulatory changes and trends with the relevant stakeholders.
What you will bring:
These are the skills and experience you will need to succeed as the Regulatory Affairs Senior Manager (Oncology):
- Proven ability to plan, coordinate and lead activities simultaneously on multiple projects.
- Confident decision-maker and ability to think strategically.
- First-rate communication and interpersonal skills.
- Solution and detail-orientated; well organised and self-motivated.
- A minimum of 5 years of experience in global regulatory affairs in global regulatory affairs.
- A minimum of 8 years of previous experience in the pharmaceutical industry.
- Bachelor’s degree in the life sciences or medical sciences.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- 10% bonus
- Subsidised travel
- Medical insurance
Got what it takes?
To apply for the Regulatory Affairs Senior Manager (Oncology), click the ‘Apply’ button below or contact the Executive Search Consultant – Kaitlin Francis – 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.