Specialist Consultants
in the Pharma Sector

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 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

I am currently seeking a Clinical Leader (Orthopedics) for a growing life science company. You will be involved in the Clinical Education for orthopedic products & services whilst also providing guidance and expertise to the clinical/scientific affairs team.

They are consistently investing heavily in their own production and so you will be involved in exciting cutting-edge developments and be working at the forefront of a highly innovative team.

The company has been rapidly growing year on year and so this is an excellent opportunity to join an expanding agency and benefit from fast progression in an exciting environment.

Experience Required

• Degree in related field, MD or DO with Orthopedics focus preferred
• Previous Clinical experience
• Experience within Scientific Affairs

Those with this experience will have the chance to join a fast-moving & innovative company.

Please contact Oliver Jones today on 6174204128 or via email at [email protected]

If you are looking to break into an industry-based Scientist position or take the step up to a Senior level, this Pharma start-up in the Greater Boston area would be keen to hear from you.

The company has expanded rapidly over the past year due to continued success and investment, and so this is an excellent opportunity to join an expanding team and benefit from fast progression in a forward-thinking environment.

They are consistently investing heavily in their own production and so you will be involved in exciting cutting-edge developments and be working at the forefront of a highly innovative team.

Experience Required

• PhD with 0-5 years of Post Doc or industry experience
• Immunology experience
• Tissue Culture experience
• Ability to work in a fast-paced environment

The successful candidate will have the choice to join a highly collaborative team and be a part of the companies fast-moving growth.

Please apply below or contact Oliver Jones on LinkedIn or via the Nonstop Consulting website.