Head of Regulatory Affairs, Pharmaceutical, USA
Regulatory Affairs Director- API Production- Innovative & Generic Drug Production
My client is looking for a new Head of Regulatory Affairs to manage their North American operations, as well as be a part of building the Global Strategy.
In this role you will:
Ideally we will need for the Head of the Regulatory Affairs team to have at least 7 years experience and be extremely hands on and capable of managing teams in multiple locations.
In this Regulatory Affairs positon you will be in a 1000people strong division, set to really ramp up and grow in the immediate future. Your position is critical to growing the business as you will essentially set the regulatory strategy for North America. They have an incredible pipeline of new products set to launch so it couldn't be a better time to join!
The company have had significant investments into their US site with expansion ongoing. With benefits like an excellent bonus scheme, private medical and an enhanced pension scheme they really do reward their staff.
- Creates Regulatory Affairs strategies and budgets for North America sites and monitors group progress against these expectations.
- Aids commercial pipeline projects through customer ANDA/NDA knowledge and strategy alignment.
- Responsible for assuring site regulatory registrations and fee payments on schedule.
- Assure DMF updates are completed in alignment with global/regional requirements based on commercial strategy.
- Responsible for planning and tracking regulatory filing priorities for NA and reporting to sr. management team
- BS or equivalent in Chemistry or related Science
- Minimum of 10 years experience within Regulatory Affairs for an FDA/EMA regulated industry
- Minimum 10 years experience with regulatory agency correspondence and deficiency processes related to drug products/drug substances
- Minimum 5 years directly coaching, managing performance, motivating and development of staff members
- Minimum 5 years experience creating Regulatory strategy options for commercial business
- Expert knowledge in drug development studies and associated documentation needed for regulatory filings
- Direct experience creating, updating and filing DMFs or CEPs and/or ANDA/NDAs
- Working knowledge of US, Canada, EU GMP, and ICH Q7, M7, Q3
To apply call me, Funmi Gbadamosi on 617 420 4128 for a confidential discussion. Please send your CV in MS WORD format to firstname.lastname@example.org
If this does not sound like the right opportunity for you, feel free to contact me about other Regulatory related positions I am working on.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of APSCo life science group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in Boston USA
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