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ASSOC DIR BIOSURGERY REGULATORY AFFAIRS (RK)
Pharmaceutical / Biotech
Root of Jobs - Research & Development
United States - Massachusetts - Cambridge
Jobs ID - 916864
Benefits - Full
Relocation Assistance Available - Possible for the ideal candidate
Bonus Eligible - Yes
Interview Travel Reimbursed - Yes
Responsible for ex-US Clinical Trial Application (CTA) submissions to national competent authorities (to include initial submissions, amendments, notifications and report), the level of support to vary depending on whether a CRO or affiliate is performing the submission. Analysis of regulatory issues and guidelines related to clinical trials. Responsible for accuracy and content of submissions and communications with regulatory bodies. Responsible for supporting efforts to comply ...
We have a Contract opportunity with a prominent client for a Senior Associate II, Regulatory Affairs in Cambridge, MA.
*Must possess exceptional communication skills (both written and verbal)
*Will be required to communicate with all levels within the organization
Job Title: Senior Associate II, Regulatory Affairs
Responsible for ex-US Clinical Trial Application (CTA) submissions to national competent authorities (to include initial submissions, amendments, notifications ...
~~Hawkins Point Partners has an immediate need on its Cambridge, Massachusetts team for a Regulatory Affairs Manager with recent experience supporting FDA Clinical Trial Application (CTA) submissions. This person will ensure initial trial submissions, amendments, notifications and reports from internal and CRO or affiliate submissions. Strong knowledge of the pharmaceutical clinical process along with analysis of regulatory issues and guidelines related to clinical trials is a core position ...
The Vice President, Clinical Quality Assurance (CQA) is charged with the development and implementation of the company's Global Clinical and Pharmacovigilance Quality Assurance Plan in alignment with both business objectives and regulatory requirements. Clinical Quality Assurancedevelops and implements all Good Clinical Practice (GCP) activities for the company and supports the Good Laboratory Practices (GLPs) related to research activities and clinical trial management. CQA ...
Sr. International Regulatory Affairs Specialist
Location: Braintree, MA
Our client is a global medical device and healthcare services organization. They are building out their International Regulatory Affairs team and need an experience associate! This position is requiring an individual with a strong background in medical device regulatory affairs within the following regions: Asia-Pacific (APAC), Latin America (LATAM) and Europe (EU).
The Sr. International Regulatory Affairs ...
Manager, International Regulatory Affairs
Location: Braintree, MA
Our client is a global medical device and healthcare services organization. They are building out their International Regulatory Affairs team and need an experienced mentor to lead the group. MUST have a strong background with medical device regulatory affairs in the following regions: Asia-Pacific (APAC), Latin America (LATAM), Europe (EU).
Accountable to drive and complete all regulatory submission and ...
Our client is looking for a contracts manager in Weston, MA.
This role will oversee the GMA-Hemophilia group responsible for setting up a Contracts Management database, liaise with Finance and Legal groups to ensure financial and reporting obligations are achieved for each agreement; monitoring and tracking all contract obligations, including event alerts to ensure event completion.
-Must have strong understanding of Contracts and Outsourcing, including understanding of legal, ...
A scientific degree in an appropriate biomedical subject (e.g. Pharmacy, Pharmacology, Chemistry, Biology, Medicine, etc.). Advanced degree preferred.
A minimum of 5 years work experience in Regulatory Affairs, preferably within the biologics/biotechnology area
Extensive knowledge of respective national procedures and requirements
This position will require considerable teambuilding, cross divisional work, conference calls and emails. Therefore, the following skills are crucial: ...
Mar 11 -
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