Senior Specialist, Regulatory Affairs - CMC

Job Description

Senior Specialist, Regulatory Affairs - CMC

JOB DESCRIPTION SUMMARY

The Senior Specialist is a member of the CMC-LCM team responsible for the preparation and review of information required for the maintenance of regulatory CMC dossiers for existing commercial products. The Senior Specialist participates in developing CMC regulatory submission strategies and timelines in accordance with global regulations and regulatory quality standards.

MAJOR ACTIVITIES AND RESPONSIBILITIES

Work independently and effectively to manage, maintain and author regulatory CMC dossiers sections, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country in order to maintain existing product registrations.

• Review technical reports and scientific information provided to support regulatory submissions.
• Identify potential risks and propose mitigation strategies; communicate potential regulatory issues to management, as needed.
• Critically evaluate health authority questions with the respective country operations regulatory affairs (CORA) and lead the team of cross-functional subject matter experts (SME) and stakeholders, when needed, to compile the responses in order to author and submit the responses timely to meet health authority deadlines.
• Actively participate in other project teams and initiatives and deliver on all assigned regulatory milestones.
• Maintain regulatory information in accordance with processes and procedures to support regulatory compliance.
• Identify and communicate potential regulatory issues to LCM team or management, as needed.
• Able to adapt and adjust to changing priorities

70% to 80%

• Annual Reports for US: prepare and submit Minor Changes and Stability Report (MCSR) and respond to associated health authority questions in coordination with the CMC product managers.
• Registration Renewals: prepare and send out documentation required to support license renewal activities and respond to associated health authority questions in coordination with the CMC product managers.

20% to 30%:

• Variations and Supplements: work effectively with stakeholders to author and send out variations and supplements and respond to associated health authority questions in coordination with the CMC product manager.
• Document management: support the relevant functions and regulatory information management systems (e.g., ALEXX-Submission, Alexx Registration, RA-Online Archive); maintain a clear and standardized filing/archive system for dossiers and correspondence.
• Continuously build and share knowledge of CMC-related global regulations and guidelines, authority expectations, as well as current industry standards, while also helping to coach others in a collaborative manner, using good communication and interpersonal skills
• Performs other tasks as requested by management.

QUALIFICATION PROFILE

Education

• Bachelor of Science degree (minimum) in Pharmacy, Chemistry or other relevant field (advanced degree preferred)

Skills Required:

• At least 4 years of direct Regulatory experience and 2 years of other relevant experience (for example: pharmaceutical research, manufacturing, analytical methods, or quality)
• Proficient in English
• High level of professionalism
• Demonstrated oral and written communication skills
• Able to work independently, with little direction, and in a team environment across multi-functional disciplines
• Computer skills: Microsoft Office suite, SharePoint

Preferred Skills:

• Systems: Veeva RIMS, CVM eSubmitter, eCTD

Competencies Required:

• Leadership and strategic thinking (problem solver, ability to deal with multiple priorities, strong interpersonal, listening, negotiation skills)
• Ability to manage multiple projects with high level of organization and planning
• Demonstrated understanding of cross-functional relationships across the business (manufacturing, packaging, quality control and assurance, marketing and supply chain)
• Experience reviewing scientific information with sound judgement and attention to detail

Required Skills

Adaptability, Detail-Oriented, Employee Training Programs, Professional Etiquette, Project Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Experience, Regulatory Submissions, Risk Management, US Regulatory Affairs, Writing Technical Documents

Preferred Skills:

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/2/2026*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:R398127