Description
Position overview – Basic functions and responsibilities
Under the direction of the Regulatory Affairs Manager, the incumbent:
1. Manages regulatory activities for new products in order to get products to market quickly.
2. Handles timely submission and follow-up of post-approval labeling and quality variations.
3. Ensures permanent compliance to local regulatory requirements and to Merck’s policies and procedures.
4. Demonstrates clear leadership in shaping the regulatory environment to support Subsidiary’s objectives.
5. Keeps abreast on regulatory environment evolution and challenges, provides advice on resulting strategy.
Primary Activities / Results
1. New products registration
- Develops, drives and finalizes all applications for new product registrations in line with local regulatory requirements and with marketing plans. Ensures 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, ensures adequate follow-up with regulatory Agencies/local partners and addresses quickly Agencies’ requests on quality, clinical and non-clinical information.
- Coordinates actions effectively and proactively with MMD and marketing, in order to support products launches in due time and to avoid stock-out situations.
2. Maintenance of existing products:
- Ensures 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, MMD, EEMEA Regulatory Affairs and Regulatory Affairs at US Headquarters (HQs).
- Manages the renewal process in liaison with the US HQs & external partners, ensuring that the renewal files are prepared, submitted and approved in due time.
- Handles the packaging components artworks development and maintenance. Coordinates the approval process and the follow-up of the printing process to ensure proper implementation of artworks changes.
3. Regulatory Compliance:
- Updates and implements local regulatory procedures in a timely manner, in close synergy with the Regional organization.
- Trains appropriate personnel on regulatory procedures.
- Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures.
- Prepare SOPs and update for compliance
4. Shape regulatory environment:
- Pro-actively shares intelligence on competitive products, generics/copies, as well as on emerging regulations.
- Establishes and develops close interactions with our distributors.
- Keeps abreast of trends and legislation, at both national and international levels.
5. Make proposals:
- Provides advice and recommendations to Management and to Regional organization on regulatory policy and applicable strategy in order to accelerate regulatory approvals while securing compliance.
6. Project work
- Collaborate with commercial colleagues and gives input on commercial agreement between distributors and MSD to secure that regulatory aspects and accountability of the distributors is well defined and in alignment with our regulatory operations.
- Participate in business deal project with HQ, HH, regional regulatory Affairs and local Regulatory Affairs lead,
- Initiate or be part of optimization project.
- Products rationalization: assessment of the products not marketed and share with commercial colleagues to take decision to maintain or delete or divest. Initiatives for better focus on medical and business needs in different market,
- Pack rationalization initiative specifically for low volumes of sales.
- Be part of subject matter expert if needed
Participate to pricing discussion with market access and commercial colleagues if needed
Qualifications
· Degree of Pharmacist or equivalent plus specialization in regulatory field
· Minimum 2- 3 year experience in Regulatory Affairs
· Resident in Casablanca .
· Clear leadership
· High sense of organization
· Rigor and reliability – Negotiation skills
· English fluency
