Director, Regulatory Affairs SSDM

Job Description

The SSDM Director role reports to the SSDM Sr Director and will be responsible to ensure the delivery of all regulatory milestones related with strategy, planning, development, submission, registration, approval, and life cycle maintenance of Pharmaceutical Products Registration in compliance with our company standards and local applicable regulations and ensure issues are identified and resolved, and opportunities for improvement of the business processes are pursued for the processes in scope of SSDM (i.e.: Renewals, Deletions, Mergers, Acquisitions, Transfers, Legal Entities changes, Site name changes, Tender Bids, CPPs, ancillary documents and artwork implementation). The SSDM director will partner cross functionally within GRACS and cross divisionally where applicable. This position will manage a team of regulatory professionals at various levels of the organization and will require enterprise-wide collaboration with external and internal partners within MRL and MMD.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

Must be hold a MS degree in pharmacy or other life science. An approx. minimum of 4-5 years’ experience in a Registration Department or equivalent, which should include dealing directly with regulatory Agencies. The incumbent must be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products. The incumbent would be expected to have had at least 3 years’ experience in a supervisory position.

Ability to communicate well verbally and in writing is essential, and good organizational and planning skills. The incumbent should possess a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work. A mature and disciplined approach to work is essential as is the ability to coordinate the work of others. The incumbent should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties. The incumbent must demonstrate proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet.

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

07/30/2024

*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.