Regulatory Affairs Senior 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.

Basic Functions & Responsibilities:
Essential functions include, but are not limited to:
For assigned products, ensures timely preparation, submission and appropriate
follow-up of new Marketing Authorization applications to the local
authorities.
Ensures maintenance of assigned, authorized products through timely submission
of variations, renewal applications, and supplemental marketing
authorizations.
For assigned products ensures timely, accurate and compliant labeling
translations and artwork preparation.
For assigned products and tasks, stays updated on late pipeline filings,
relevant regional and local regulations, and guidelines and to develop and
maintain positive relationship with key players in the regulatory environment.
Designs and implements regulatory ad-hoc local action plans, as necessary.
Collects relevant publicly available regulatory information (regulatory
intelligence) and keeps relevant persons appropriately informed.
Maintains a positive relationship with internal and external regulatory
contacts.
Applicable to incumbent with direct reports only: Responsible for people
management of applicable Regulatory personnel in Saudi Arabia and provides
clear leadership.
Secures appropriate career development for the applicable staff and is
responsible for keeping the applicable staff scientifically and legally
updated within the regulatory area.
Acts as substitute for Country Lead Regulatory Affairs as appropriate.

Major activities include, but are not limited to:
New Marketing Authorization applications for assigned products:

Performs timely and correct submission and approval of assigned new Marketing
Authorization applications in close cooperation with relevant persons in the
managing, medical, finance, customer service, marketing and external affairs
departments, on sub-regional, regional and global level, as well as with local
regulatory authorities as appropriate, depending on procedure type.
Coordinates and implements early access programs with the Agency.
Tracks process and manages answers to objections from the Agency on products
registration and major new indications, involving negotiations to achieve best
conditions.
Designs and implements local action plans for new products, involving
selection and regulatory training of external experts and closely interacting
with the Agency and Advisory Committee members.

Maintenance of licenses for assigned products:
Ensures that marketing authorizations are maintained in compliance with
related regulatory areas, through performing the necessary activities,
including variations and renewals, with a high standard and within the agreed
timeframes and communicates approvals to stakeholders through the correct
processes.
For major indications, designs and implements local action plans as above
mentioned for new Marketing Authorization applications.

Compliance:
For assigned products, ensures timely preparation and maintenance of local
summary of Product Characteristics, Patient Package Inserts, local physicians'
circulars, packaging material and other applicable regulatory documents
according to our company local standards and procedures.
Implement Prescribing Information within the correct timeframes for
compliance.
Ensures that all internal customers receive relevant information with regard
to the regulatory status of the assigned products.
Ensures the correct and proper utilization to generate mockup artwork and to
implement revisions to artwork.
Ensures efficient and consistent implementation and use of internal and
external regulatory databases and systems in the country.
Ensures that files and archives related to regulatory are kept updated and
completed.
Participates in establishing and maintaining of relevant Standard Operating
Procedures to secure that the current regulations are complied with.
Participates in implementation of updated regulatory documentation according
to Agency requirements and in-house guidance.

Labeling and artwork:
Ensures high quality translations and check of Summary of Product
Characteristics and Patient Package Leaflets including linguistic check of
these documents.
Ensures availability of packaging material, including package leaflets and all
other artwork in a timely and correct manner and according to relevant
procedures.

Cross-functional activities:
Obtains early information about new studies to be able to advice on Clinical
Trial Applications and study planning as appropriate to the local group
responsible for Clinical Trials.
Ensures adequate support to other functions to enable compliance in areas
related to regulatory, such as submissions and review of promotional material.
Provides regulatory guidance and support to the license companies/joint
venture/co-marketing partners as appropriate.
Secures timely and adequate information and decision making with regard to
regulatory issues that need to be brought to the attention of the Management
Team.
Takes part in subsidiary product and launch teams to provide regulatory input
and strategy advice.
Participates, provides active input and lead if the case the local Medical
Governance.

Regulatory environment:
Keeps abreast of local and international laws.
Through active participation in the regulatory work of the local
Pharmaceutical Industry Association the incumbent seeks alignment of industry
position with our company interests.
Shapes the regulatory environment through liaising with the local agency,
local pharmaceutical organization and other stakeholders, and in concurrence
with the Global & EEMEA Regulatory Policy lead.
Participates in internal registration managers' meetings at sub-regional and
regional level and EEMEA regulatory workgroups on selected issues.
For new regulations, identifies and tracks changes/trends that might impact
our company business.
Participates in task forces of Pharmaceutical Industry/Agency.

Manage direct report, as applicable:
Sets up priorities, organizes, oversees, and monitors direct report's
activities, towards division's and country's objectives achievement in
compliance with policies and standards.
Ensures that direct reports are trained for their proper use of internal
regulatory systems.
Through attendance to courses/workshops ensures that staff is appropriated
updated on new legislations, requirements on regulatory.
Manages, coaches, and develops talent.
Maintains a scientific knowledge and expertise for therapeutic areas of our
company.
Fosters a positive team spirit of the staff.

Qualifications:
Must be hold a MS degree in pharmacy.
A minimum of ‎4 years’ experience in a Registration Department or equivalent,
which should include dealing directly with regulatory Agencies.
The incumbent must be familiar with local and regional legislation procedures
and guidelines governing pharmaceutical products.
Must know how to work in a team.
Collaborate with different departments.
Shows flexibility in work and travel.
Strong communication skills.
Good English.

We are a research-driven biopharmaceutical company. Our mission is built on
the simple premise that if we “follow the science” that great medicines can
make a significant impact to our world. We believe that a research-driven
enterprise dedicated to world-class science can succeed by inventing medicine
and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United
States and Canada and MSD everywhere else. For more than a century, we have
been inventing for life, bringing forward medicines and vaccines for many of
the world's most challenging diseases. Today, our company continues to be at
the forefront of research to deliver innovative health solutions and advance
the prevention and treatment of diseases that threaten people and animals
around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an
Impact in all aspects of our business, enabling breakthroughs that will affect
generations to come. We encourage you to bring your disruptive thinking,
collaborative spirit and diverse perspective to our organization. Together we
will continue Inventing For Life, Impacting Lives while Inspiring Your Career
Growth.

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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
Work Week

Shift:
Not Indicated

Valid Driving License:
Yes

Hazardous Material(s):
Requisition ID: R185919