Merck Sharp & Dohme
Senior Principal Scientist (Senior Director) | Regulatory Affairs Liaison
Merck Sharp & Dohme, Rahway, New Jersey, us, 07065
Job Description
We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our pipeline and drive our strategic priorities.
Summary, Focus and Purpose
The Senior 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.
You will independently manage projects, functioning as the single, accountable, global point of contact on those projects and independently interact with Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics. Programs may be complex with more than one indication, formulation and/or have an external business partner.
Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all submissions and associated documentation. Provides expertise as 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.
Key Functions
Reports to Executive Director or Associate Vice President, General Medicine
Works Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Develops worldwide product regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously
Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling
Provide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within and external to GRACS on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
Provide 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 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
Coordinate interactions with foreign agencies through Regulatory Affairs Europe and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously
Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from our company to external agencies and investigators
Represent GRA within internal company committees to provide regulatory advice and approval according to the committee charters (including therapeutic area Document Review Committees, Product Development Team, Early Development Team, and label development team)
Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials
Participate in regulatory due diligence activities for licensing candidate review
Education
B.S. or M.S with a minimum of 10 years of relevant drug development experience with majority in regulatory
M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience with five years in regulatory
Experience | Skills | Knowledge
Required
Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead
Skilled/experienced in assessing global regulatory/competitive landscape to establish global regulatory strategies that facilitate speed to market while delivering targeted product labeling
Strong verbal and written communication skills
Preferred
Substantial experience with immunology, neuroscience and/or ophthalmology development programs
Small and large molecule experience
Substantial experience in Regulatory Affairs
NOTICE FOR INTERNAL APPLICANTSIn 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.
US and Puerto Rico Residents Only:
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.
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.
Expected US salary range: $181,600.00 - $285,800.00
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Employee Status:
Regular
Requisition ID:
R315188
#J-18808-Ljbffr
We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our pipeline and drive our strategic priorities.
Summary, Focus and Purpose
The Senior 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.
You will independently manage projects, functioning as the single, accountable, global point of contact on those projects and independently interact with Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics. Programs may be complex with more than one indication, formulation and/or have an external business partner.
Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all submissions and associated documentation. Provides expertise as 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.
Key Functions
Reports to Executive Director or Associate Vice President, General Medicine
Works Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Develops worldwide product regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously
Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling
Provide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within and external to GRACS on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
Provide 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 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
Coordinate interactions with foreign agencies through Regulatory Affairs Europe and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously
Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from our company to external agencies and investigators
Represent GRA within internal company committees to provide regulatory advice and approval according to the committee charters (including therapeutic area Document Review Committees, Product Development Team, Early Development Team, and label development team)
Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials
Participate in regulatory due diligence activities for licensing candidate review
Education
B.S. or M.S with a minimum of 10 years of relevant drug development experience with majority in regulatory
M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience with five years in regulatory
Experience | Skills | Knowledge
Required
Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead
Skilled/experienced in assessing global regulatory/competitive landscape to establish global regulatory strategies that facilitate speed to market while delivering targeted product labeling
Strong verbal and written communication skills
Preferred
Substantial experience with immunology, neuroscience and/or ophthalmology development programs
Small and large molecule experience
Substantial experience in Regulatory Affairs
NOTICE FOR INTERNAL APPLICANTSIn 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.
US and Puerto Rico Residents Only:
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.
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.
Expected US salary range: $181,600.00 - $285,800.00
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Employee Status:
Regular
Requisition ID:
R315188
#J-18808-Ljbffr