Job Description
We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our pipeline and drive our strategic priorities.
The Director, Principal Scientist | Regulatory Affairs Liaison is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the General Medicine therapeutic area, with a specific focus on development programs in Immunology, Neuroscience and/or Ophthalmology. The individual functions with a high degree of independence and provides regulatory oversight for assigned products, to optimize product labeling and obtain shortest time to approval by global regulatory agencies.
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- Reports to Associate Vice President, Executive Director, or Senior Director in the General Medicine Therapeutic Area.
- Independently manages projects within the General Medicine Therapeutic Area, with a focus on Immunology, Neuroscience and/or Ophthalmology, functioning as the single, accountable, global point of contact on those projects.
- Develops global regulatory strategy for their assigned products, to optimize labeling and obtain shortest time to approval by regulatory agencies.
- Functions as global regulatory lead assigned to programs where the compound is first-in-class or is in a new therapeutic area for our company; where no regulatory guidance exists; where the program is accelerated; has an external business partner; there are multiple indications, the filing is global and/or it is a new disease target with no official regulatory guidance.
- Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling
- Independently interacts with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more our company's investigational and marketed drugs.
- Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions.
- Responsible for regulatory review and final approval of all submissions and associated documentation.
- Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
- Provides leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
- Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
- Represents our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our company's teams for meetings with FDA at any phase of drug development. Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
- Coordinates interactions with foreign agencies through Regulatory Affairs Europe (RAE), Regulatory Affairs International (RAI), and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
- Reviews and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from our company to external agencies and investigators.
- Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
- Represents GRACS within our company's internal committees to provide regulatory advice and approval according to the committee charters. (Therapeutic area document review committees (DRC), Global Regulatory Team (GRT) Product Development Team (PDT), Early Development Team (EDT), and Labeling Working Groups).
- Participates in regulatory due diligence activities for licensing candidate review.
Minimum Education & Experience Requirements:
- Degree in biological science or related discipline
- B.S., with minimum of 7 years of relevant drug development experience
- M.S. with minimum of 7 years relevant drug development experience
- M.D. with minimum of 3 years relevant drug development experience or clinical experience
- PhD/PharmD with minimum of 5 years relevant drug development experience
Required Experience:
- Demonstrated ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.
- Strong verbal and written communication skills
Preferred Experience:
- Small and large molecule experience
- Skilled/experienced in assessing global regulatory/competitive landscape to establish global regulatory strategies that facilitate speed to market while delivering targeted product labelin
- Substantial experience in Regulatory Affairs
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$164,800.00 - $259,400.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/23/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R315213