Sr Mgr Regulatory Affairs
Sr Mgr Regulatory Affairs
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Salary Not Disclosed
1 Vacancy
Job Description
At Regeneron were advancing science and medicine to improve lives. Were seeking a talented Regulatory Affairs Manager to join our team and play a pivotal role in supporting EU regulatory activities for oncology drug development. This is your chance to contribute to groundbreaking clinical development programs while collaborating with global experts and building relationships across the EU regulatory network.
Join us in shaping the future of oncology treatments and making a meaningful impact on patients lives.
A Typical Day:
As a Regulatory Affairs Manager your day might include:
- Developing regulatory strategies for oncology programs by researching guidelines EU precedents and emerging trends.
- Managing CTA submissions via CTIS for multiple EU member states ensuring compliance with EU requirements.
- Organizing preparing and reviewing CTA amendments annual reports and other regulatory documents.
- Performing critical analyses of clinical and preclinical data to develop interpretations and conclusions.
- Leading EU Scientific Advice requests and coordinating EMA and EU national agency meetings.
- Monitoring newly published EU Commission and EMA guidelines to ensure compliance and provide training for scientific staff.
- Representing Regeneron Regulatory Affairs in engagements with EMA scientific committees EU national agencies and industry associations.
This Role May Be For You If:
You are someone who:
- Thrives in a collaborative environment and enjoys working with multidisciplinary teams.
- Has a proven ability to navigate EU regulatory frameworks and requirements.
- Is detail-oriented and skilled in analyzing clinical and preclinical data.
- Has experience leading regulatory agency meetings and negotiating effectively with stakeholders.
- Is passionate about contributing to oncology drug development programs.
- Values continuous learning and stays updated on emerging regulatory trends.
- Has excellent written and verbal communication skills.
To Be Considered:
Were looking for candidates with:
- An advanced degree in a scientific discipline.
- At least 4 years of regulatory experience with a focus on clinical development.
- Proven experience supporting EU Clinical Trial Applications through approval and study start-up.
- Familiarity with EMA processes such as scientific advice orphan designation and PIPs.
- Experience in oncology regulatory strategy is an advantage.
- A strong ability to negotiate and express clear positions to stakeholders at all levels.
- Preferred qualifications include experience with marketing authorization applications or life-cycle management of approved products in the centralized procedure.
Why Join Us
At Regeneron we believe in fostering innovation collaboration and growth. Youll have the opportunity to work with a passionate team dedicated to advancing science and improving patient outcomes. Together well make a difference.
Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits which often include (depending on location) health and wellness programs fitness centers equity awards annual bonuses and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion or belief (or lack thereof) sex nationality national or ethnic origin civil status age citizenship status membership of the Traveler community sexual orientation disability genetic information familial status marital or registered civil partnership status pregnancy or parental status gender identity gender reassignment military or veteran status or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Companys business.
For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.
Required Experience:
Manager
Employment Type
Full-Time
