Sr. Manager, Regulatory Affairs - Combination Products
Company: Pfizer
Location: Lake Forest
Posted on: April 6, 2021
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Job Description:
Sr. Manager, Regulatory Affairs - Combination Products Act as
the regulatory core team member for, and provides regulatory
guidance to combination product project teams in a fast paced,
highly visible, complex, and at times ambiguous and changeable
environment. Will provide guidance to other combination product
regulatory professionals. ROLE RESPONSIBILITIES Ability to present
all information (regulatory and scientific) effectively, both
orally and in writing, in a concise, logical, and persuasive manner
with excellent written and interpersonal communication skills.--
Provides guidance on drug and device regulations, regulatory
strategy, and pharmaceutical and design controls/design history
file deliverables to other combination product regulatory
professionals. Is responsible for the creation of all submission
documentation for a project with a large portfolio of products.
This includes correspondence, meeting requests and dossier content,
including labeling. Set and communicate timelines for the
regulatory submissions and for the delivery of supporting
documentation. Ability to work with all functional areas to obtain
needed information on time. Anticipates the impact of potential
team decisions on the regulatory strategy, timelines, project
goals, and other programs and influence the team as needed. Reviews
scientific information to ensure the data is complete, sound,
logical, and supports the program goals.-- Partners with authors to
ensure supporting information is clearly and logically written, in
order to ensure it is submission ready.-- Interact and effectively
negotiate with regulatory authorities Maintains awareness of
applicable regulations and guidance and informs project teams of
new information, along with its possible impact to the project, as
appropriate. Interprets regulations and ensures regulatory
compliance. -- Exercises good judgment within company policy and
health authority regulations. Candidate demonstrates a breadth of
diverse leadership experiences and capabilities including: the
ability to influence and collaborate with peers, develop and coach
others, oversee and guide the work of other colleagues to achieve
meaningful outcomes and create business impact. PHYSICAL/MENTAL
REQUIREMENTS: Must be able to work in an office environment and at
a computer or on the phone throughout the day. The field of
combination products is relatively new and in flux, both in the US
and ex-US. The successful individual will embrace the ambiguity in
how to meet the intent of both the device and pharmaceutical
regulations simultaneously, the continual change in expectations,
and the ability to possibly influence company precedent. This
position requires an evaluation of the candidate's writing skills.
BASIC QUALIFICATIONS Bachelor's degree in pharmacy, nursing,
biology, chemistry, pharmacology, engineering or a related subject;
is required. 10-15 years of experience in regulatory affairs in
Medical Devices or Combination Products. Medical Device Regulatory
Affairs experience required. Strong understanding of the intent of
the regulations to wisely navigate the discrepancies that exist in
the application of each set of regulations to combination products,
in order to ensure the decisions work well throughout the lifecycle
of the products and to set appropriate precedent for future
products and projects.--
--- PREFERRED QUALIFICATIONS A Master's degree is preferred. A
Ph.D. is highly preferred. Previous experience with combination
product regulatory strategy and/or execution is strongly preferred.
ADDITIONAL OFFER DETAILS Additional Locations: USA - Remote Last
Date to Apply for Job: April 23, 2021 Eligible for Relocation
Package Eligible for Employee Referral Bonus: Yes #LI-REMOTE For
roles based in Colorado: The annual base salary for this position
ranges from $118,900 to $198,100. In addition, this position offers
an annual bonus with a target of 17.5% of the base salary and
eligibility to participate in our share based long term incentive
program. Benefits offered include a retirement savings plan, paid
vacation, holiday and personal days, paid caregiver/parental and
medical leave, and health benefits to include medical, prescription
drug, dental and vision coverage in accordance with the terms and
conditions of the applicable plans. Sunshine Act Pfizer reports
payments and other transfers of value to health care providers as
required by federal and state transparency laws and implementing
regulations. These laws and regulations require Pfizer to provide
government agencies with information such as a health care
provider's name, address and the type of payments or other value
received, generally for public disclosure. Subject to further legal
review and statutory or regulatory clarification, which Pfizer
intends to pursue, reimbursement of recruiting expenses for
licensed physicians may constitute a reportable transfer of value
under the federal transparency law commonly known as the Sunshine
Act. Therefore, if you are a licensed physician who incurs
recruiting expenses as a result of interviewing with Pfizer that we
pay or reimburse, your name, address and the amount of payments
made currently will be reported to the government. If you have
questions regarding this matter, please do not hesitate to contact
your Talent Acquisition representative. Pfizer is committed to
equal opportunity in the terms and conditions of employment for all
employees and job applicants without regard to race, color,
religion, sex, sexual orientation, age, gender identity or gender
expression, national origin, disability or veteran status. Pfizer
also complies with all applicable national, state and local laws
governing nondiscrimination in employment as well as work
authorization and employment eligibility verification requirements
of the Immigration and Nationality Act and IRCA. Pfizer is an
E-Verify employer. Regulatory Affairs#LI-PFE Pfizer careers are
like no other. In our culture of individual ownership, we believe
in our ability to improve future healthcare, and potential to
transform millions of lives. We're looking for new talent to join
our global community, to unearth new innovative therapies that make
the world a healthier place.
Keywords: Pfizer, Lake Forest , Sr. Manager, Regulatory Affairs - Combination Products, Executive , Lake Forest, California
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