Associate Director, Regulatory CMC
Jazz Pharmaceuticals, Raleigh, NC, United States
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
Brief Description: The Associate Director position, Regulatory Affairs Global CMC is responsible for establishing global regulatory CMC Strategies for commercial and development projects in line with the global regulatory strategy.
The Associate Director will have a strategic role in driving CMC Regulatory Strategies across multi-disciplinary teams, including leading the preparation of regulatory CMC submissions. Essential Functions Lead
s
activities that include planning
content
, authoring where
appropriate
,
reviewing
and approval of
Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents), in support of Global Regulatory Team Objectives.
Provide in-depth reviews of protocols, reports, presentations, and documents for CMC Development or Commercial product team, as
required
.
May
represent
Reg-
CMC
at
related regulatory agency interactions for team
products
,
and
manage the preparation and review of material for agency interactions
.
Provide
timely
updates
of
CMC Regulatory Strategy for the Global Regulatory Strategy document for assigned projects, as
required
and securing functional support.
Lead
the preparation and submission of responses to regulatory
agencies
are managed appropriately and in
a timely
fashion.
Regularly interact with functional leaders, on matters concerning CMC regulatory strategy, including regulatory agency interactions
to ensure functional alignment
.
Lead GRA-CMC or GRA projects / initiatives that significantly
impact
the business globally.
Identify
and lead continuous improvement opportunities for the GRA-CMC team and the broader GRA team.
Ensure continued regulatory compliance of products
though
adherance
to
c
hange control and Regul
a
tory Information Management procedures, completing the regulatory impact assessment of changes and ensuring
appropriate implementation
planning is executed.
Ensure compliance with company policies,
procedures
and training expectations
Required Knowledge, Skills, and Abilities
Demonstrated understanding and strategic application of regulations and guidelines for drug
lifecycle activities
.
Demonstrated knowledge of CMC regulatory and ability to generate clear, well-argued positions.
Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations,
responses
and CTAs/INDs).
Demonstrated understanding of FDA,
EMA
and ICH guidelines.
Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
Demonstrated ability to influence and
impact
their functional area and department practices.
Required/Preferred Education and Licenses
BSc/BA with a minimum of
eight
years of regulatory CMC
or related
experience.
English language - written and verbal communication skills
.
#LI-SM1 #LI-remote
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $156,000.00 - $234,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here:
https://careers.jazzpharma.com/benefits.html .
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
Brief Description: The Associate Director position, Regulatory Affairs Global CMC is responsible for establishing global regulatory CMC Strategies for commercial and development projects in line with the global regulatory strategy.
The Associate Director will have a strategic role in driving CMC Regulatory Strategies across multi-disciplinary teams, including leading the preparation of regulatory CMC submissions. Essential Functions Lead
s
activities that include planning
content
, authoring where
appropriate
,
reviewing
and approval of
Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents), in support of Global Regulatory Team Objectives.
Provide in-depth reviews of protocols, reports, presentations, and documents for CMC Development or Commercial product team, as
required
.
May
represent
Reg-
CMC
at
related regulatory agency interactions for team
products
,
and
manage the preparation and review of material for agency interactions
.
Provide
timely
updates
of
CMC Regulatory Strategy for the Global Regulatory Strategy document for assigned projects, as
required
and securing functional support.
Lead
the preparation and submission of responses to regulatory
agencies
are managed appropriately and in
a timely
fashion.
Regularly interact with functional leaders, on matters concerning CMC regulatory strategy, including regulatory agency interactions
to ensure functional alignment
.
Lead GRA-CMC or GRA projects / initiatives that significantly
impact
the business globally.
Identify
and lead continuous improvement opportunities for the GRA-CMC team and the broader GRA team.
Ensure continued regulatory compliance of products
though
adherance
to
c
hange control and Regul
a
tory Information Management procedures, completing the regulatory impact assessment of changes and ensuring
appropriate implementation
planning is executed.
Ensure compliance with company policies,
procedures
and training expectations
Required Knowledge, Skills, and Abilities
Demonstrated understanding and strategic application of regulations and guidelines for drug
lifecycle activities
.
Demonstrated knowledge of CMC regulatory and ability to generate clear, well-argued positions.
Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations,
responses
and CTAs/INDs).
Demonstrated understanding of FDA,
EMA
and ICH guidelines.
Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
Demonstrated ability to influence and
impact
their functional area and department practices.
Required/Preferred Education and Licenses
BSc/BA with a minimum of
eight
years of regulatory CMC
or related
experience.
English language - written and verbal communication skills
.
#LI-SM1 #LI-remote
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $156,000.00 - $234,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here:
https://careers.jazzpharma.com/benefits.html .