V.S. International Pvt. Ltd Recruitment 2023 .V.S. International Pvt. Ltd Notification full details below. Interested and eligible candidates can Send Resume. V S International (VSI) is a manufacturer with a global presence in several fast-growing & emerging markets. Our products are manufactured in our EU-GMP certified facility located in India. The said facility has also been audited and certified by regulatory authorities from various countries. We are also manufacturers and Exporters of Laboratory equipment, Hospital & Lab Furniture, Medical Electronics & Hospital Consumables.
Vacancy details:
- Post Name: Asst. Manager/Sr. Executive/Executive – Regulatory Affairs
- Qualification: B.Sc in Any Specialization, B.Pharma in Any Specialization/MS/M.Sc(Science) in Any Specialization, M.Pharma in Any Specialization
- Experienced:03 to 8 years
- Salary: 3-7 Lacs P.A.
Job Description: Greeting from V S International Pvt Ltd, Daman & Diu!
Important Details :
- Location: Mumbai( Worli )
- Post of date:25/02/2023
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face
- Interview Rounds of Interview: HR
Roles and Responsibilities
Executive – RA (Position -02)
- Compiling and preparing of the CTD/ ACTD/ ECTD dossiers for regulatory and semi-regulatory markets.
- Coordinating with the Plant and Purchase department for relevant documents.
- Reviewing of the relevant documents.
- Coordinating with CMO partners for relevant modules of the dossiers.
- Reviewing Artwork labels.
- Updating and modifying the artwork with country specific requirements.
- Coordinating for translations, if needed.
- Responding to queries from the Health authorities.
- Handling variation for existing registrations or MAs.
PG Dip or Training in RA would be preferred
Assistant Manager (Position – 01)
- Reviewing and submitting documents on time for registration as well as renewal of the products in MOH
- Keeping track of registration expiry
- Coordinating and submitting registration samples on time to partners
- Keeping a track of available ODMF from various API manufacturers
- Replying to MOH queries related to product registration by coordinating with the CFTs
- Interacting with marketing for registration and customer interaction.
- Exploring the possibilities of leveraging existing MAs and registrations to various markets.
- Providing Management with regulatory pathway suggestions to broaden the registration portfolio
- Studying scientific and legal documents, including agreements
- Gathering, evaluating, organising, managing and collating information in a variety of formats.
- Ensuring compliance with regulations set by regulatory agency
- Maintaining familiarity with company product ranges
- Coordinating and analysing BA/BE trials with external agencies
- Keeping up to date with changes in regulatory legislation and guidelines
- Liaising with MOH /FDA for online submission of licences and COPPs for getting approval
- Liaising with the Legal consultants for preparing the documents like COPP, Mfg. Lic and FSC for Notary, Apostilsation and Legalised process for various countries.
- Writing comprehensible, user-friendly, clear product information leaflets and labels
- Ensuring that quality standards are met and submissions meet strict deadlines
- Coordinating with F&D for initiating new projects for taking batches and samples
- Ensuring finished goods are in line with Marketing authorization and in case of changes, evaluating and filing appropriate variations.
- Keeping complete track on Artwork cycle – Processing, intervention and approval till finalization
- Getting necessary approvals on Artworks from concerned departments and required documents for preparing the dossiers.
- Ensuring timely payments to vendors and outsource parties.
- Getting Invoice /Packing list to courier the registration samples and documents for various countries
- Co-ordination for getting approval of Approval of MSDS on time whenever required for smooth transport/export
- Generating item codes for Packing material
- Building and managing a stable, disciplined and result-oriented team, with successful leadership.
- Participating in the Manpower Planning and Selection process so as to ensure optimum staffing and hire the right fit.
- Allocating tasks or responsibilities to team members as per their skills and setting priorities as per the requirements.
- Identifying the training needs of the team members and fulfilling these through formal training as well as hand-holding, guiding, coaching.
- Setting targets for the team and the team members, monitoring and reviewing performance and taking necessary actions; so as to achieve growth / revenue targets.
- Resolving conflicts, if any.
- Maintaining employee morale by creating safe and efficient working environment.
- Motivating /mentoring/ counselling to achieve desired performance.
- Identifying, rewarding and retaining high performers to create future leaders
Desired Candidate Profile
Degree in Pharmacy /M.Sc / B.Sc
Good knowledge of ICH guideline and country wise guidelines
To prepare the ACTD and CTD dossiers without queries
Knowledge to prepare the Artworks as per Mock-Up
Working knowledge of relevant soft wares and IT tools
Perks and Benefits
As per Candidature
Interested candidate may apply or send their updated resume in the given mail ID with the following details.
Email: gita.hr@vsinternational.co.in
Total Experience:-
Current CTC:-
Expected CTC:-
Notice Period:-
Website: http://www.vsinternational.co.in
