Job Abstract

Job Description

The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's Research & Development Division by:

• Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.

• Contributing to the continuous improvement of the operating model for regulatory activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.

• Providing quality advice to stakeholders creating optimal development, commercialization, and drug/delivery device supply strategies 

• Building our leadership and functional capability to keep pace with the changing science and regulatory environment.

• Establishing and effective implementation and oversight model to maintain best in industry regulatory compliance.

The Vice President Regulatory Affairs, General Medicine is accountable for:

• Directing and Supervising the General Medicine Therapeutic Area (Regulatory)

• Directing and supervising Worldwide Product Labeling

• Directing and supervising the US Office of Promotion and Advertising Review

• Directing and supervising the US Subsidiary regulatory operations

• Directing and supervising the Drug Device/Combination Products Center of Excellence

• Providing strategic and tactical direction and execution of cross product and GRACS cross functional projects and teams as assigned.

Key Accountabilities:

• Directs activities of the General Medicine global regulatory therapeutic area and team leading to global innovative and accelerated regulatory strategy and marketing authorizations for Cardiovascular, Diabetes, Respiratory, Immunology, Neuroscience and Women’s Health programs. Prioritizes and oversees execution of high quality and timely health authority engagement in attaining desired results. Reviews and defends stage-gate deliverables for programs including risk assessment and mitigation plans and engages in corporate governance meetings overseeing the progress of those development programs.

• Inspires a high level of performance in a dynamic environment, leaning into areas of talent management and succession planning, operational efficiency and compliance, and external collaboration and influence through industry affiliations and relationships with health authorities. Leads, develops, and coaches a team of senior level employees to effectively manage programs and enable rapid and effective decision making through empowerment of individuals. Embodies leadership behaviors to interact and increase effectiveness by enabling clear, concise communication directly to senior management at our company.

• Partners with members of GRACS Leadership Team to provide guidance on the application of regulatory activities with cross- product or cross-functional impact, including drug device/combination products and software as medical device platforms.  Reviews and resolves issues that span diverse areas and manages situations that are viewed as precedent setting.  Guides internal teams to implement rigorous, innovative, and science-based approaches to regulatory interactions and requirements.  Uses enhanced business acumen, strategic understanding of the regulatory environment globally and thinks beyond functional and divisional lines to drive decisions and strategies that are innovative, impactful and in our company's best interest.

• Partners with members of GRACS Leadership Team to help our company build solid and trustworthy relationships with FDA and global health authorities. Pro-actively influences and manages relations with FDA and global health authorities to build consensus and ensure our company's regulatory strategies are implemented.

• Partners with members of GRACS Leadership Team to strengthen our collaboration with our company's Chief Patient Office, Global Human Health (Commercial), Center for Observational and Real-World Evidence (CORE) and our Manufacturing Division internally to create a single voice of commitment to regulatory strategies that accelerate and maintain access of product through market authorization, execute of post marketing commitments and meet compliance obligations.

Education:

• M.D. or PhD with >20 years relevant experience preferably with >15 years in Regulatory or M.S. or B.S. with >25 years relevant experience a majority of which was in Regulatory.

Required Experience and Skills:

• Global Regulatory experience required across various modality types.

• M.D. or PhD with >20 years relevant experience preferably with >15 years in Regulatory or M.S. or B.S. with >25 years relevant experience a majority of which was in Regulatory.

• Demonstrated scientific knowledge, analytical ability, and effective written and verbal communication skills. 

• Demonstrated organizational leadership and management skills.

Job Specific Competencies & Skills:

• Demonstrated ability to understand, manage and lead in a multi-cultural atmosphere, with an employee base that is distributed globally.

• Proven leadership and management skills with cross-functional teams, as well as inspiration and motivation skills.

• Ability to set strategic goals in line with the business.

• Excellent interpersonal communications, organizational, and presentation skills.

• Superior negotiation and influencing skills.

• Demonstrated experience with budgeting and planning.

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

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.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement?

Pay Transparency Nondiscrimination

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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, generally Tuesday, Wednesday and either Monday or 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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:

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.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.