We know making a career change can be like a leap of faith. We also know how much of an impact a right or wrong move can have on your life.
That is why we first take the time to get to know you – your wants, needs and aspirations. We then work tirelessly to match you with an employer that both matches your requirements and is the right cultural fit for you.
Many of our candidates have been referred to us by other candidates, a testament to our quality of service.
So, why do candidates choose us?
Roles of genuine interest: Because our consultants are true experts within their niche markets, they have a detailed understanding of the roles, responsibilities and nuances in your field, as well as of employers. This means they can connect you with opportunities you will be genuinely interested in.
Global coverage, local knowledge: Our consultants work in teams each specialising in one technical discipline and geographic area meaning you benefit from in-depth coverage within your region yet still have access to roles across the globe should you wish – a key advantage when only a small percent of vacancies are actually advertised.
High quality service: Underpinned by our in-house Quality Assurance team, our relationship with candidates is fully transparent and truly consultative. Our consultants pay attention to every detail and pride themselves on being open and honest, ensuring the right opportunities for you as well as valuable feedback. We are active members of APSCo, the Association of Professional Staffing Companies, and the ASA, the American Staffing Association, both recognised badges of quality with the recruitment industry.
Full suite of opportunities: Permanent, fixed term, or freelance positions available.
Latest Vacancies
Regulatory Affairs Manager, Devices, Colorado
North America
£120K per Year
January 21, 2020
Ref: FG295264_1579648014
Permanent
Regulatory Affairs Manager, Medical Device Denver- Colorado rec... Read more
Regulatory Affairs Manager, Medical Device Denver- Colorado
We are currently working with a Medical Device Company in Denver/ Louisville area to recruit a new Regulatory Affairs Manager.
The Senior Regulatory Affairs Manager will be responsible for U.S. and CE marking product activities related to submissions and registration and working effectively with other country regulatory coordinators to provide submission/registration documentation with strategic planning and revenue drivers in consideration.
In addition, the manager will oversee the activities of the department by managing priorities and providing guidance and development of department employees.
Requirements:
* Minimum of 8+ years worldwide regulatory affairs medical device submission registration experience.
* Minimum of 5 years personnel managerial experience
* Must have knowledge and Experience with IEC 60601 is critical
* BS or BA degree in technical area such as biology, chemistry, physiology, engineering, medical or law.
Responsibilities:
* Execute divisional driver goals by meeting department objectives.
* Manage, plan, and coordinate department activities.
* Accountability for assurance that products are in compliance with FDA and European regulatory submission/registration requirements.
* Internal collaboration with regulatory coordinators for other geographic regions (i.e. Japan, Asia, Canada and Australia/New Zealand) to provide requested product information and format (i.e. International dossiers and STED) for successful submissions/registrations.
If you would like to discuss in further please call Funmi (Senior Executive) on 617 420 4128
Alternatively email [email protected]
Regulatory Affairs Manager, API Devens, MA
North America
£120K per Year
January 21, 2020
Ref: FG2107456/5_1579647816
Permanent
Regulatory Affairs Manager pharmaceutical - API Production- Innovative Drug Production ... Read more
Regulatory Affairs Manager - 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 [email protected]
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
Senior Researcher Epidemiology Boston
North America
£Neg
January 21, 2020
Ref: OG236482/1_1579646488
Permanent
EPIDEMIOLOGIST/ SENIOR RESEARCHER ... Read more
The Researcher will collaborate with epidemiologists, biostatisticians, programmers, project managers, clinicians, and others, to provide epidemiology expertise in support of multiple pharmacoepidemiology research projects for a portfolio of clients in the life sciences industry.
As a result of their growth they can offer flexibility with location, we can currently offer:
Wilmington DE
Greater Boston MA
Alexandria VA
Requirements:
* Epidemiology background (at least 1 year)
* Proficiency in SAS statistical software is required.
* Proficiency in R statistical software is highly desired.
Responsibilities:
* Lead or support the design and execution of pharmacoepidemiology research,
* Provide epidemiology subject matter expertise and lead or support research activities.
* Lead and/or contribute to the development of protocols, statistical analysis plans, reports, and publications.
* Lead or support the development of detailed specifications for study databases and analysis files
As an employee you will be eligible for all the perks this company can offer including but not limited to a competitive salary and of course top of the industry healthcare packages.
Alternatively email [email protected]
