Dir, Sr Regulatory Affairs - Allergan (santabarbara, CA)
Title:
Dir, Sr Regulatory Affairs 1.
Submissions:
:
Independently plans and prepares complex regulatory documents for product approval.
:
Independently resolves submission problem areas.
:
Independently prepares complex expository and technical documents, logically constructed and comprehensive in content.
:
Ensures effective coordination and implementation of regulatory activities in support of new product approval/registration and maintenance in all markets 2.
Advisory
Responsibilities:
:
Participates in and/or leads global teams.
:
Collaborates and advises the team on resolution complex project issues.
:
Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements.
:
Evaluates opportunities for accelerated approval and/or early access to products in development :
Defines regulatory requirements for initiatives in support of regional business needs 3.
Communications:
:
Prepares documentation that is complete, accurate, and on time.
:
Delivers business and educational presentations within the Company as required.
4.
Regulatory Compliance:
:
Approves manufacturing process changes as appropriate.
:
Reviews promotional, advertising, labeling and packaging components to ensure accuracy and compliance with governmental regulations.
Education and Experience Education equivalent to a BS degree in a scientific field, plus 13 years experience in regulatory affairs; or MS degree in a scientific field, plus 11 years experience in regulatory affairs; or a PhD degree in a scientific field, plus 8 years experience in regulatory affairs Class III medical device experience required.
10 years of increasing responsibilities in management of health care product development including regulatory affairs.
Significan Source:
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Dir, Sr Regulatory Affairs 1.
Submissions:
:
Independently plans and prepares complex regulatory documents for product approval.
:
Independently resolves submission problem areas.
:
Independently prepares complex expository and technical documents, logically constructed and comprehensive in content.
:
Ensures effective coordination and implementation of regulatory activities in support of new product approval/registration and maintenance in all markets 2.
Advisory
Responsibilities:
:
Participates in and/or leads global teams.
:
Collaborates and advises the team on resolution complex project issues.
:
Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements.
:
Evaluates opportunities for accelerated approval and/or early access to products in development :
Defines regulatory requirements for initiatives in support of regional business needs 3.
Communications:
:
Prepares documentation that is complete, accurate, and on time.
:
Delivers business and educational presentations within the Company as required.
4.
Regulatory Compliance:
:
Approves manufacturing process changes as appropriate.
:
Reviews promotional, advertising, labeling and packaging components to ensure accuracy and compliance with governmental regulations.
Education and Experience Education equivalent to a BS degree in a scientific field, plus 13 years experience in regulatory affairs; or MS degree in a scientific field, plus 11 years experience in regulatory affairs; or a PhD degree in a scientific field, plus 8 years experience in regulatory affairs Class III medical device experience required.
10 years of increasing responsibilities in management of health care product development including regulatory affairs.
Significan Source:
.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
