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Senior Manager, Regulatory Affairs GRA HBU Brands - US

Employer
Pfizer
Location
La Jolla, California; Collegeville, Pennsylvania; Peapack, New Jersey
Salary
Competitive
Closing date
Dec 16, 2021

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma
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All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Right now, we are seeking for a highly qualified candidate to fill the following position:

GRA HBU Brands Senior Manager - US

Role Summary:
  • Provide regulatory support for assigned portfolio within Brands as a Global Regulatory Strategist (US-based) as an individual contributor. Directly accountable for providing strategic regulatory guidance for projects/products through regulatory strategists for the portfolio. Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines.
  • Directly accountable for ensuring that the development and implementation of Regulatory Strategies including assurance that project prioritization, strategies, labeling, submissions, approvals, post-marketing lifecycle management activities, etc., are in place and delivered in accordance with time, cost and quality expectations.
  • Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.
  • Act as liaison with regulatory authorities to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.
  • Leads and/or participates in Regulatory Teams for assigned projects/products.
  • Develops and implements regulatory strategies to support/maintain registrations. Maintains product licenses across all product platforms.
  • Understands regulatory environment and communicates priorities to global stakeholders.


Responsibilities:
  • Ensure appropriate) contribution to global regulatory strategies and implementation plans (including core labels, risk registers) for assigned projects/products in portfolio.
  • Partner with project teams and other customer groups (e.g., BU, commercial teams, etc.) to ensure regulatory contributions (strategies, labeling, submissions, approvals, post-marketing lifecycle management activities, etc.) achieve the objectives in the strategy, achieve agreed standards, and minimize resource demands while maximizing overall project delivery time and probability of success and facilitating post filing activities.
  • Ensures regulatory plans are monitored, progress/variance communicated to GRPL and Senior Management and any risks from emerging technical data, changing internal objectives or external threats are mitigated
  • Ensures an aligned regulatory position is reached and communicated for all key issues for assigned projects/products, and that these regulatory positions supporting the business are championed and communicated.
  • Works closely with other Regulatory and CMC Product managers within, and across, sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
  • Implements systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.
  • Engages in appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.
  • Ensures business compliance and implementation of and adherence to Regulatory standards.
  • Develops and maintains constructive working relationship with Health Authority contacts.


Qualifications:
  • B.S. Scientific Degree required. An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.
  • In depth and relevant Global and/or US regulatory experience. Proven experience in managing global and/or regional regulatory process and registration aspects of the drug development process and post-marketing lifecycle management in the Pharmaceutical Industry, preferably in Regulatory Affairs/Health Authority and/or a proven track record of success in negotiating with Health Authorities and in representing interests to internal and external stakeholders. Experience managing multiple products simultaneously and different stages of the product lifecycle is highly desirable.
  • Proven ability in developing and implementing regulatory strategy: Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs/ MAAs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling, meeting corporate expectations.
  • Knowledge of assigned therapeutic areas/disease areas is preferred Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
  • Proven ability to partner successfully with Regulatory, Commercial, Safety, Medical and other partner lines to achieve objectives Experience in successfully communicating with major regulatory agency(ies), including leading and participating in such interactions, is preferred.
  • Proven ability to deliver in a highly matrixed organization. Knowledge of drug development practice rules, Regulations and guidelines: Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
  • Proven examples of delivery across the product's lifecycle with demonstrable contribution in Regulatory Affairs.
  • Proven ability to consistently deliver to time, cost, and quality standards.
  • Presentation skills: Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers as well as senior management.
  • Communication skills: Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
  • Negotiation skills. Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations.


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.

Other Job Details:

Last Date to Apply for Job:12/21/2021
Additional Location Information:United States - New York - New York City; United States - California - La Jolla; United States - Connecticut - Groton; United States - New Jersey - Peapack; United States - Pennsylvania - Collegeville; United States - Remote
NO Relocation Package
Eligible for Employee Referral Bonus

#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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

#LI-PFE
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