We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Senior Manager Regulatory Affairs
- Act as a key regulatory affairs consultant, providing expertise and innovative solutions to clients and internal teams on regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications.
- Provide senior review and oversight on Regulatory projects.
- Maintain knowledge of changing regulatory requirements and advise teams as appropriate (Regulatory Intelligence).
- Represent client regulatory affairs team as needed.
- Provide strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements.
- Liaise with regulatory authorities on behalf of clients (e.g., US Agent)
- Build, develop and maintain working relationships with clients
- Support marketing, business development and sales activities to drive new business through proposal writing, pricing, budget estimates, presentations, etc.
- Oversee Regulatory Affairs project forecast, budget, scope, and resources.
- Assist to continually improve North American Regulatory Affairs processes.
- Mentor and train junior staff.
- 6+ years of experience and broad knowledge in the field of Regulatory Affairs
- Strong critical thinking and leadership skills
- Results focused approach.
- Generics, drugs, biologics, food, veterinary experience a plus.
- Experience with planning, preparing, and filing FDA IND/NDA/BLA original applications, IND/NDA/BLA maintenance submissions, HC CTA/IMPD/NDS
- Ability to work in a growing, fast-changing environment and adapt to resource and knowledge gaps in client and internal RA teams.
- Good understanding of the North American regulatory landscape, especially in regards to Health Authority regulations, guidance documents, processes, and timelines.
- Excellent skills in moderating and presentation
- Strong command of the English language
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.