Director, Global Regulatory Affairs & Clinical Safety Business Development

Job Description

Under minimal guidance from the Senior Director, Business Development, the incumbent is responsible for representing Regulatory Affairs on business development transactions from deal initiation through potential signing. More specifically, this position will oversee staff who will manage the business development stages of strategy, evaluation, due diligence, contracting, implementation support and maintenance of regulatory activities relating to our Company business partner deals.  The scope of transactions to be supported include but are not limited to divestitures, mergers/acquisitions, in-licensing, and collaborations.

Responsibilities:

• The Director will have people management responsibilities that require oversight of team members in supporting the range of Business Development opportunities.  Additionally, the incumbent will assume the responsibilities for employee development and management consistent with Company leadership principles.

• Work with the staff to manage the strategy, negotiation, and provisions of regulatory components of agreements as they relate to product acquisitions, collaborations, distribution, comarketing, copromotion, tech transfer, joint ventures, and divestitures.

• Collaborate with all functional areas within Global Regulatory Affairs and Clinical Safety as well as Corporate Business Development, Clinical Research, Commercial, Manufacturing, and other groups as deals require.

• Support the development of new Business Development agreements with a focus on Regulatory aspects, for complex deals.  Maintain existing agreements that require updating as the partner relationship evolves over time.

• Have oversight across multiple projects with potentially complex integration points and fast paced timelines.  This will require helping the staff assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations and/or resolve the problem. 

Education requirement:

• Bachelor’s degree. At least 7 years’ experience in the pharma industry or adjacent field such as Health Authority.

• Advanced degree, preferably in Regulatory or other science discipline, would be a plus. 

Required Skills:

Preferred Skills:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

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