Regulatory Affairs Manager Clinical Trials (m/f/x) | Munich | Pharma
In this role you will be serving as the European regulatory coordinator and support for assigned projects, products and non-project work in the area of Clinical Trials. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally to become a fully recognized support function of clinical study teams and relevant stakeholder, providing support to EU regulatory strategists. Represent Regulatory Affairs working with authorities, affiliates, partners and CROs.
What will your tasks as Regulatory Affairs Manager Clinical Trials be?
- Act as a regulatory contact person for European clinical trial matters as well as the EU interface with CROs for regulatory submissions related to clinical trials
- Organize and coordinate Clinical Trial submissions in accordance with applicable regulations and guidance and manage / support clinical trial submissions in the EU
- Review and interpret regulatory guidelines, especially the CTR and provide guidance to peers and direct reports regarding regulatory issues
- Participate in clinical study team meetings; provide regulatory support and guidance as required for the preparation of documents required for regulatory submissions for example Investigational Medicinal Product Dossier (IMPD) or Response to Queries
- Advises the regulatory strategist and EU product leads on CTA submission strategy and evaluates the adequacy of the content of regulatory submissions and identifies deficiencies requiring further resolution
- Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders. Also communicates with outside consultants (i.e. CRO's) as needed
- As assigned by manager participate or lead assigned non-project tasks and process improvements
What does the position offer you?
- Type of contract: unlimited + full time
- Vacation: 30 days / year
- Working hours: 40 hours / week
- Salary: Basic salary (13)
- Benefits: Opportunities for further qualification, a pleasant working atmosphere in a committed team, flat hierarchies and short decision-making paths, various internal and external catering options, options for childcare in the surrounding area, wide range of health and sports activities (e.g. company doctor); highly flexible working model; attractive remuneration and benefits offer
- Accessibility: On-site parking and very good public transport connections
- Start date: As soon as possible
- Location: Downtown Munich
- Homeoffice: Currently 100% remote; 1-3 days Homeoffice negotiable after COVID
Your requirements as Regulatory Affairs Manager Clinical Trials?
- Life Sciences degree; Master of Drug Regulatory Affairs is a plus
- ca. 3 years experience in working with Clinical Trials
- Experience of working in global environment, with CROs, National Health Agencies and EMA
- Proven ability to plan, coordinate and lead submission activities simultaneously
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization
- Solution and detail-oriented; well-organised and self-motivated.
- Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner.
- Excellent written and oral communication skills in English, any other language is a plus
Information about our client:
The company is one of the 20 largest pharmaceutical companies in the world and operates in 16 European countries. With over 15,000 employees in 20 countries, the company develops and markets innovative medicines for patients in the field of hypertension, thromotic diseases and in the field of oncology. Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!
I look forward to your application!