1+ months

Sr. Manager, Regulatory Affairs

Lake Forest, IL 60045
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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.


+ 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.


+ 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.


+ 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 Locations:** USA - Remote

+ **Last Date to Apply for Job: April 23, 2021**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus: Yes


**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.

**EEO & Employment Eligibility**

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

Posted: 2021-03-11 Expires: 2021-04-29
Sponsored by:
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Sr. Manager, Regulatory Affairs

Lake Forest, IL 60045

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