Group Regulatory Affairs Manager - Aalst, België - Ontex

Ontex

Geverifieerd bedrijf

Aalst, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Date: 13-Feb-2023- Employment Schedule: Full time- Location: Aalst, BE
Group Regulatory Affairs Manager:
Ontex is a leading international producer of personal hygiene solutions for babies, women and adults. We distribute in more than 110 countries through leading retailer private labels, as well as under our own brands. The group employs over 10,000 employees, spread around the world. Ontex is listed on Euronext Brussels.

Our people are our most valuable asset. To support and reinforce our R&D team we are looking for a Group Regulatory Affairs Manager.

The Group Regulatory Affairs Manager understands and translates global regulatory, scientific, operational and business knowledge into effective product regulatory strategies and implementation plans for Ontex's consumer goods, therapeutic goods, cosmetics, and medical devices.

1.

Regulatory Frameworks and Strategy:

Develops and updates global, regional and multicountry regulatory strategy and seeks opportunities for innovative approaches to meeting regulatory requirements.
Establishes working relationships and interfaces with multiple government and nongovernment organisations impacting market access and distribution.
Implements regulatory intelligence to assist in developing local, regional and global regulatory strategies.
Identifies the need for and manages the development, approval, and execution of new regulatory standard operating procedures (SOPs).
Identifies the need for and manages the development, approval, and execution of new regulatory standard operating procedures (SOPs).
Identifies regulatory pathways for initial product designs and works with internal stakeholders to determine the final regulatory strategy.
Provides indepth understanding and ability to incorporate regulatory strategies to expedite product development.

2.

Product Development and Registration:

Reviews and assesses proposals to regulatory authorities on regulatory submissions and clinical plans.
Provides strategic input and technical guidance on global regulatory requirements to product development teams.
Evaluates product risks and preclinical and clinical safety issues during product lifecycle and recommend regulatory solutions.
Leads crossfunctional teams for interactions with regulatory authorities
Provides regulatory guidance on strategy for proposed product claims/labelling.
Ensures that the clinical and nonclinical data in conjunction with organisational objectives are consistent with the regulatory requirements and support the proposed product claims.
Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
Leads key negotiations and interactions with regulatory authorities during critical stages of the development and review process.
Provides knowledge and critical analysis and may participate in preapproval inspections, GCP inspections, audits and clinical investigator relationships.
Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and suggested plans for changes that do not require submissions.

3.

Postapproval/Postmarket:

Develops, implements, and manages appropriate SOPs and systems to track, manage and report and communicate productassociated event complaints, recalls, market withdrawals and vigilance reports.
Adapts and supervises the implementation of postmarket strategy in conjunction with crossfunctional partners based on consideration of factors such as reimbursement, state/provincial/regional restrictions and other legislative/regulatory requirements for handling recalls and communication to stakeholders.
Reviews and approves change controls to determine the level of change and consequent submission requirements assesses potential impact on business objectives, and communicates that impact accordingly.
Ensures process is in place for review and approval of advertising and promotion, maintaining annual licenses, registrations and listings to ensure regulatory compliance.
Develops, implements and manages systems to track required reports, supplemental submissions and other postmarketing commitments.
Reviews and approves required reports, supplemental submissions and other postmarketing commitments to maintain product registrations.

4.

Business acumen:

Supports integrated regulatory process and system improvement initiatives that will influence and build new capabilities for greater effectiveness and efficiencies.
Represent the organisation with a thorough understanding and communication of legislation, regulations, guidance, policy and directives.
Creates a culture of good information practices and protection/safeguarding of information.
Uses financial analysis to generate, evaluate and act on strategic options and opportunities to support business decisions and manage and develop a budget.
Assesses and approves work plans to ensure appropriate staging of activities