Regulatory Affairs Specialist

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Position Overview - Basic Functions And Responsibilities

Under the direction of the designated Senior Specialist, Regulatory Affairs, the incumbent will

Manage regulatory activities for new products in order to get products to market quickly.

Handle timely submission and follow-up of post-approval labeling and quality variations.

Ensure permanent compliance to local regulatory requirements and to policies and procedures.

Demonstrate active support for the agreed to Subsidiary objectives.

Keep abreast on regulatory environment evolution and challenges.

Primary Activities / Results

New product registrations in Lebanon, Jordan and Iraq

Develop, drive and finalize all applications for new product registrations in line with local regulatory requirements and with marketing plans. Ensure submission in a timely manner and follow-up to obtain earliest approvals for new products and new claims.

During the assessment of the registration files, perform adequate follow-up with regulatory Agency(ies)/distributors and address Agency requests on quality, clinical and non-clinical information in a timely manner.

Coordinate actions effectively and proactively with our manufacturing division and marketing, in order to support products launches in due time.

Build strong relationships with Regulators/ Distributors to obtain factual information on progress of submissions.

Maintenance of existing products

Ensure timely submission and follow-up of both labeling and quality-related variations to the marketing authorizations, in cooperation with the key stakeholders Worldwide Product Labeling, our manufacturing division, MEA Regulatory Affairs and Regulatory Affairs at US Headquarters (HQs).

Collaborate with Artwork – co-ordinator to ensure timeous development of packaging component artworks Ensure proper implementation of artwork changes.

Build strong relationships with Regulators to obtain factual information on progress of submissions.

Regulatory Compliance

Update and implement local regulatory procedures in a timely manner, in close synergy with the Regional organization.

Plan and track all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures. Ensure regular update of global tracking systems.

Ensure packaging material compliance within the Artwork Management System AMS blue

Regulatory environment

Pro-actively share intelligence on all regulatory aspects Relating to individual products, competitive products, generics/copies, as well as on emerging regulations.

Establish and develop close interactions with relevant regulatory Authorities, opinion leaders and professional associations.

Keep abreast of trends and legislation, at both national and international levels.

Project work

Collaborate with commercial colleagues and provide input to secure regulatory aspects are well defined for commercial operations.

Participate in business deal projects with HQ, HH, regional regulatory Affairs and local Regulatory Affairs Lead

Actively participate in rationalization initiatives specifically for low volumes of sales.

Become a subject matter expert in available aspect of RA work

Qualifications

Pharmacist or equivalent qualification with experience in regulatory field

Minimum 3 years of experience in Regulatory Affairs

Must be based in Lebanon

Good sense of organization

Committed team player

Rigor and reliability

Persistence

Negotiation skills

English fluency

Analytical mind

Time management

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply 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

Regular

Relocation

VISA Sponsorship

Travel Requirements

Flexible Work Arrangements

Hybrid

Shift

Valid Driving License

Hazardous Material(s)

Requisition ID R283743

Full time