Regulatory Affairs Director - New Jersey
TMC is looking for an enthusiastic Regulatory Affairs Director who will provide leadership on global clinical regulatory activities. Responsibility will mainly focus on regulatory filings and on providing strategic as well as operational leadership for the project teams in this area. In addition, responsibilities will include support to ongoing clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for clinical assets.
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| Your challenges?
- This role requires the ability to integrate and apply knowledge of global regulations governing pharmaceutical drug development of all aspects of quality, preclinical and clinical drug development programs, policies and procedures, so that Development teams can meet all objectives within specified timelines and so that the state of compliance is maintained to all regulatory commitments/requirements.
- Develop regulatory strategies for assigned programs in collaboration with Regulatory senior management.
- Provide regulatory analysis, guidance and assessment of drug(s) developed for similar indication to obtain approval of activities in support of development and marketing objectives within targeted timelines.
- In charge of communication with FDA and health authorities for assigned programs.
- Manage and lead regulatory activities associated with assigned drug development programs.
- Oversee the planning, preparation and submission of licensing applications (BLA/MAA).
- Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs.
- Provide training on applicable requirements for scientific staff as the need arises.
- Manage and mentor direct team members and/or junior staff.
| What do we expect from you?
- MD, Ph.D. or Pharm D. required
- A minimum of 10 years of pharmaceutical industry experience, at least 5 of which should include regulatory affairs
- Must possess excellent written, verbal communication and presentation skills
| What can you expect from TMC?
TMC is an international high-tech consultancy company that brings expertise to their clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster changing technological world.
At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career.
As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.
| Why choose for Employeneurship?
We are truly unique thanks to our Employeneurship model which is a true innovation for the High Technology consulting business. It is the business relationship of the 21th century for high skilled technical professionals. It is built around 5 main pillars:
- You will have a permanent employment contract, offering you stability and security
- You will get to know your market value and have a share in the profit your work generates thanks to the individual profit sharing
- We will support you with a one-on-one coaching and trainings designed to help you develop your entrepreneurial skills
- The competence cells structure, provides you with a strong meaningful and relevant network
- The entrepreneurial lab: a playground for new ideas and a potential launching for start-ups
TMC is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Is TMC a perfect fit for you? We’d love to hear from you.
Feel Free to Contact
Talent Acquisition Specialist, North America
Tel: +1 (438) 686 5994