Regulatory Affairs Specialist

il y a 4 semaines


Lyon, France Barrington James Temps plein

Lyon, France
- 11-05-2023
- JOB TYPE
- Permanent
- EMP TYPE
- Full-Time
- EXPERTISE
- Regulatory Affairs
- SALARY TYPE
- Annually
- SALARY
- Negotiable

I have partnered with a rapidly growing pharmaceutical company with a focus on developing innovative and effective drugs to address unmet medical needs. Our mission is to improve patient outcomes and make a positive impact on the healthcare industry. I am seeking a highly motivated Regulatory Affairs Specialist to join our team in Lyon.

As a Regulatory Affairs Specialist, you will be responsible for ensuring that our pharmaceutical products comply with all relevant regulations and guidelines. You will work closely with cross-functional teams to develop and execute regulatory strategies, prepare and submit regulatory submissions, and communicate with regulatory authorities.

Key Responsibilities:

- Develop and implement regulatory strategies for assigned products
- Prepare and submit regulatory submissions, including INDs, NDAs, and BLAs
- Ensure compliance with applicable regulations and guidelines, including FDA and EMA requirements
- Communicate with regulatory authorities to address questions and provide additional information as needed
- Work collaboratively with cross-functional teams to ensure timely and accurate submission of regulatory documents
- Keep up-to-date with changes in regulations and guidelines, and communicate potential impact on product development and regulatory strategies
- Support regulatory compliance activities, such as labeling and advertising/promotion review
- Participate in regulatory agency meetings and negotiations as needed

Qualifications:

- Bachelor's degree in life sciences or related field, advanced degree preferred
- 3+ years of experience in regulatory affairs in the pharmaceutical industry
- Strong understanding of FDA and EMA regulations and guidelines
- Experience with IND, NDA, and BLA submissions
- Excellent written and verbal communication skills in English and French
- Ability to work effectively in a cross-functional team environment
- Strong attention to detail and ability to manage multiple projects simultaneously
- Strong analytical and problem-solving skills
- Ability to work independently and take ownership of projects
- We offer a competitive salary and benefits package, including health insurance, 401(k) plan, and paid time off. If you are passionate about making a difference in the lives of patients and want to be part of a dynamic and innovative team, please submit your resume and cover letter for consideration.-
T: +44 1293 776644- #LI-TH2Consultant
- Thomas Hatfield
- +441293776644



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