Senior Director Global Regulatory Affairs
5 days left
- Full Time
Senior Director for Global Regulatory Affairs
I'm currently hiring for one of my long established clients for a senior director for global regulatory affairs. The role is open as the company have grown significantly over the last few years and ultimately will look to continue this growth in the years to come with many new product launches world wide. What we look for is an experienced regulatory affairs professional with broad pharma regulatory experience across EMA/FDA, post marketing and new launches. The company are still relatively small and will need someone who can be dynamic, hands on and have a commercial mind set.
I've worked with this Pharmaceutical Company for close to 8 years now, so I'm happy to talk through case studies and the pro's and cons. The key take away is it's a good role for someone who wants to be in a smaller, more commercial environment. It's worlds apart from big pharma and there is a lot to learn here that wouldn't necessarily come up in bigger companies. The company are heavily focused on post marketing and product acquisitions, so as such, they are less focused on drug development, hence someone more interested in commercial regulatory would be needed.
If you could be interested 'In-principle' then feel free to contact me. Interest may well be high and the requirements will be very strict, so I will be open with applicants around this.
Reports into: EVP for Regulatory Affairs
- Leading a small regulatory team and a number of consultants, CROs and other vendors
- Responsible for key regulatory filings for EMA/FDA/ROW providing both oversight and leading regulatory strategy
- Oversight for some PV and medical information activities
- Able to step in and be hands for submissions, variations and overviews when needed
- A part of a number of cross functional teams working closely with project managers, QA, medical, market access, clinical and commercial functions.
- Being able to lead health authority meetings such as FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.
- A MD, PhD or PharmD qualification (Due to the PV needs we will need someone with good medical knowledge of prescriptions, if someone doesn't have these qualifications, but has some PV experience, I will consider this)
- At least 10 years experience in pharmaceutical regulatory affairs (We cannot consider experience within other industries such as medical devices)
- Strong and proven tenures through out your career with demonstrated internal growth
- Experience ideally in both pre and post approval pharma Rx launches
For a confidential discussion about this role, or to apply, then send your CV to firstname.lastname@example.org or call me, Matt Beedle, Executive partner on +41 43 50 80 81, ask to be transferred to extension 3290. Please feel free to visit my linked-in profile to see my references/recommendations.
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