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Head of Regulatory, Pharmaceutical Philadelpiia

Employer
NonStop Consulting
Location
Devens
Salary
Up to £120000 per annum
Closing date
Aug 21, 2019

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Sector
Science, Life Sciences, Cell and Molecular Biology
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate

Job Details

Regulatory Affairs Manager, in Devens- API Production- Innovative Drug Production

In this role you will: provides regulatory oversight and support to the regulatory team's assigned products as well as direct input in areas of your expertise. You will be the regulatory resource for the team's assigned products will monitor global regulatory agency publications, proposed guidances, inspection reports, and expectations to determine trends and areas of regulatory and compliance emphasis that could affect the products.

They are now looking for someone who can support this strategy whilst being a key part of the regulatory team. They are expanding rapidly across the USA and have solid financial backing.

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.

Responsibilities:

  • Prepares and oversees the preparation of global regulatory submissions (Type II DMF, ASMF, etc.) in eCTD format describing the manufacturing and controls in support of ANDA and NDA submissions.
  • Provides updates to regulatory submissions or responses to resolve any filing deficiencies. Functions as a regulatory consultant for external clients as needed. Must be able to successfully defend these documents when questioned during customer audits and regulatory agency inspections.
  • Reviews and approves associated development reports, control procedures, processing procedures, validations, test methodologies, and other required documentation which are necessary to both develop a product and also successfully transition it into routine commercial manufacture. Aids in CMC strategy to ensure the approval of commercial manufacturing submissions.

Required experience:

  • BS in Chemistry or related science with at least 5-10 years related experience in the pharmaceutical or API manufacturing industry; or a Master's degree in Chemistry or related science with 3-5 years related experience. Preferably a degree in Regulatory Affairs.
  • 3-5 years experience in Regulatory Affairs, within the pharmaceutical or API industries.
  • Experience engaging with Board of Health regulatory authorities for issue resolution is a plus
  • Knowledge of High Potency and Controlled substances manufacturing and regulatory management is a plus.
  • Experience compiling DMFs, and LOA process or CEPs and variation process is a plus.
  • Is knowledgeable of the regulations pertaining to the API industry, including but not limited to ICH Q7 and related guidance's, FDA regulations, etc.

To apply call me, Funmi Gbadamosi on 617 420 4128 for a confidential discussion. Please send your CV in MS WORD format to f.gbadamosi@nonstop-recruitment.com

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

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
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