TITLE: Senior Manager of Regulatory Affairs (cmc)
INDUSTRY: Pharmaceutical/Biotech
LOCATION: Philadelphia area
QUALIFICATIONS:
The role will have a strong CMC biologic emphasis (75%),
but will also provide general regulatory support to ongoing
projects (25%)
• Bachelor’s degree is required, advanced degree
in a scientific field is preferred.
• Generally has 7 years or more of relevant Regulatory
Affairs or related pharmaceutical experience; or equivalent
combination of education and experience.
• Experience/expertise in establishing and implementing
regulatory strategy across therapeutic areas, early development
experience with some concentration in manufacturing of biologics
a plus
• Experience/expertise in effectively communicating,
interacting and negotiating with regulatory authorities.
• Expertise to independently present complex information
to Shire senior management, consultants, regulatory authorities
and the medical community.
• Expertise to independently resolve problems and
identify areas of opportunity.
• Expertise to write scientific and technical documents
• Expertise to lead and influence regulatory and cross-functional
teams.
• Expertise in regulatory submission structure and
content (NDS, NDA, MAA)
• Expertise in motivating, mentoring and managing
teams a plus
RESPONSIBILITIES: • Helps to design
regulatory strategy for molecules in development with an
emphasis in early development (through clinical proof-of-concept).
• Implements primarily CMC regulatory strategies for
assigned project (projects)
• Responsible for helping to identify novel regulatory
approaches that will optimize development opportunity.
• Provides regulatory input and support to project
teams and effectively collaborates with key functions: including
pharmaceutical sciences, manufacturing, quality assurance,
legal/IP, program management and strategic marketing.
• Inform team of regulatory decisions, issues, potential
problems and new regulations, assessing impact on emerging
products as appropriate.
• Serves as liaison with regulatory agencies to develop
effective professional relationships as well as our positive
company image and oversee regulatory submissions.
• Provides regulatory analysis and evaluation of new
product opportunities (particularly in the early development
area) and support Senior Director in completing special
projects in support of pipeline development efforts
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TITLE: Director of Regulatory Affairs
INDUSTRY: Pharmaceutical
LOCATION: Philadelphia area
KEY RESPONSIBILTIES: responsible for developing
and directing objectives, policies and programs pertaining
to development and marketing of drug products in the US.
• Designs and implements regulatory strategies to
obtain, maintain and extend product registrations.
• Provides regulatory guidance and input to project
teams.
• Oversees the creation and submission of Regulatory
documents, e.g., INDs, NDAs., supplemental NDAs and other
relevant regulatory filings.
• Serves as corporate liaison with regulatory agencies
to develop effective professional relationships as well
as our positive company image.
• Remains knowledgeable about current regulations
and guidance, interprets and notifies appropriate personnel.
• Arranges for and leads meetings with global health
authorities as needed.
• Provides training and mentorship to regulatory staff.
• Makes recommendations for regulatory department
operating procedures.
• May be responsible for creating and reviewing SOPs
as needed.
• May supervise a changing number of Regulatory Affairs
staff
JOB DESCRIPTION: •
Expertise to effectively communicate, interact and negotiate
with regulatory authorities.
• Expertise to independently present complex information
to senior management, consultants, regulatory authorities
and the medical community.
• Expertise to independently resolve problems and
identify areas of opportunity.
• Expertise to write scientific and technical documents
• Expertise to lead and influence regulatory and cross-functional
teams.
• Proven ability/expertise to provide a strategic
vision for regulatory strategy across therapeutic areas
• Expertise to create, establish and communicate both
local and global regulatory strategy
• Expertise in regulatory submission structure and
content (NDS, NDA, MAA)
• Must have a level of expertise in each of
these areas and expertise in a subset:
o drug development knowledge and expertise (Preclinical,
Clinical, PK)
o reviewing promotional materials and negotiating changes
with the agency
o identifying and implementing changes in product labeling
• Proven ability/expertise to motivate, mentor and
manage a team
• Proven ability /expertise to develop and share best
practices within Regulatory Affairs and with other functions
• Proven ability /expertise to support regulatory
standards and philosophy
• Strong organizational skills, attention to detail,
ability to multi-task, and MS Office ability.
QUALIFICATIONS: Education and Experience
Requirements
• M.S. or Ph.D. in a scientific field is strongly
preferred
• A minimum of 7 years of Regulatory Affairs or related
pharmaceutical experience
• At least 3 years of management experience; or an
equivalent combination of education and experience.
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TITLE: Directory of Regulatory Affairs
INDUSTRY: Pharmaceutical
LOCATION: Southern California
JOB DESCRIPTION: Prepare and submit
applicable documentation to domestic and international health
authorities for the application and support of investigation
and new drug filings. This documentation includes clinical,
pharmacology, toxicology, ADME, and chemistry/manufacturing
issues. Ensure that all supporting documentation is accurate
and in accordance with regulatory requirements.
- Implement all regulatory activities in the assigned areas
for the company in collaboration with CROs and internal
departments
- Act as primary liaison to the FDA
- Act as primary liaison to CROs and regulatory consultants
and contractors
- Review, coordinate, and approve regulatory documentation
for inclusion in INDs and worldwide submissions. Coordinate
with Research and related operating departments in accomplishing
these submittals
- Participate in the planning and implementation of clinical
trial audits
- Participate in the preparation of regulatory strategies
and plans worldwide
- Identify key issues and recommend resolutions to impediments
for INDs. Coordinate with Clinical Research and Discovery
Research Management in the implementation of corrective
actions
- Regulatory reviews of protocols, reports, SOPs
- Keeping company informed about FDA and non-US new regulations
and/or requirements
QUALIFICATIONS: BS is required. MS or PhD
preferred in Pharmacology, Biochemistry, Biology or a related
science plus ten or more years experience post-doctorate,
with five to seven years in regulatory affairs. Demonstrated
proficiency in negotiating with FDA reviewers, hands-on
experience in preparing IND's and NDA's, with specific experience
in hematology and immunology. Experience in team leadership
is preferred. Experience with electronic submissions is
a must.
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