- Fri Nov 21, 2025 12:41 am#8981
JOB PREPARATION GUIDE – EXECUTIVE, GLOBAL REGULATORY AFFAIRS
1. RESEARCH THE COMPANY
• Review Square Pharmaceuticals PLC background – flagship of Square Group, certified by major international regulatory authorities, market leader in Bangladesh since 1985 and expanding into Kenya.
• Understand the company’s product portfolio, global presence, and recent regulatory milestones.
• Familiarise yourself with the corporate values, especially the emphasis on non‑smokers and zero‑cost recruitment.
2. STUDY THE ROLE DESCRIPTION
• Prepare CTD / ACTD dossiers for export markets – know the structure of Module 1‑5, electronic submission standards (eCTD), and regional differences (US, EU, Africa).
• Provide updated regulatory information – keep current on FDA, EMA, WHO, Kenya Pharmacy and Poisons Board guidelines.
• Review and prepare technical documents – be comfortable drafting manufacturing, stability, and non‑clinical sections.
• Respond to authority queries – practice writing concise responses to deficiency letters and inspection observations.
• Prepare annexure/recipes and arrange DTL samples – understand how to document formulation recipes and coordinate with the Drug Testing Laboratory.
• Check artwork for local and export markets – know labeling requirements, packaging artwork review process, and regulatory annexes.
• Liaise with internal departments – develop a systematic approach for feedback loops with R&D, Production, Quality, and Marketing.
3. MATCH YOUR QUALIFICATIONS
• Academic – M.Pharm or B.Pharm from a reputable university.
• Experience – 1‑2 years in Global Regulatory Affairs or Formulation R&D is preferred; fresh graduates may apply if they demonstrate strong knowledge of regulatory submissions.
• Skills – planning and execution, quantitative & qualitative analysis, excellent written and verbal communication, ability to work shift‑based operations, and age ≤33 years.
4. TAILOR YOUR CV
• Highlight regulatory projects: specific CTD modules you prepared, markets targeted, and outcomes (e.g., approval dates).
• Emphasise any experience with eCTD software (e.g., eCTDmanager, Veeva Vault).
• List familiarity with international guidelines (ICH Q7‑Q12, ISO 9001).
• Include any cross‑functional liaison examples and shift work adaptability.
5. CRAFT A TARGETED COVER LETTER
• Open with a statement of interest in Square Pharma’s global growth, especially the Kenya expansion.
• Align your regulatory experience with the duties listed – give brief examples of dossier preparation, query handling, and artwork verification.
• Mention your commitment to the company’s health‑focused culture (non‑smoker stance).
• Conclude with confidence in meeting the November 30 2025 deadline and readiness for a virtual or onsite interview.
6. PREPARE FOR THE INTERVIEW
• Technical: be ready to discuss CTD module details, differences between CTD and ACTD, regulatory strategy for emerging markets, and a case study of handling a major authority query.
• Practical: prepare a mock CTD Module 3 (Quality) for a hypothetical product, including a summary of manufacturing process and control.
• Behavioral: examples of teamwork with R&D and Quality, handling shift schedules, and problem‑solving under tight timelines.
• Company‑specific: knowledge of Square Pharma’s recent product launches, certifications, and strategic goals in Africa.
7. APPLICATION PROCEDURE
• Submit the application through the provided eRecruitment link before the deadline.
• Attach a PDF version of your CV and cover letter only – hard copies are not accepted.
• Do NOT pay any fees; Square Pharma does not request money at any recruitment stage.
• Ensure your profile states that you are a non‑smoker, as smokers are discouraged from applying.
8. POST‑APPLICATION FOLLOW‑UP
• After submission, monitor the email address you provided for acknowledgment and possible interview invitations.
• Keep a copy of the job reference (Ref: HR/DU‑11‑25‑378) handy for any correspondence.
• Prepare a brief “thank you” note to send after an interview, reiterating your fit for the role.
End of preparation and technical guide.
1. RESEARCH THE COMPANY
• Review Square Pharmaceuticals PLC background – flagship of Square Group, certified by major international regulatory authorities, market leader in Bangladesh since 1985 and expanding into Kenya.
• Understand the company’s product portfolio, global presence, and recent regulatory milestones.
• Familiarise yourself with the corporate values, especially the emphasis on non‑smokers and zero‑cost recruitment.
2. STUDY THE ROLE DESCRIPTION
• Prepare CTD / ACTD dossiers for export markets – know the structure of Module 1‑5, electronic submission standards (eCTD), and regional differences (US, EU, Africa).
• Provide updated regulatory information – keep current on FDA, EMA, WHO, Kenya Pharmacy and Poisons Board guidelines.
• Review and prepare technical documents – be comfortable drafting manufacturing, stability, and non‑clinical sections.
• Respond to authority queries – practice writing concise responses to deficiency letters and inspection observations.
• Prepare annexure/recipes and arrange DTL samples – understand how to document formulation recipes and coordinate with the Drug Testing Laboratory.
• Check artwork for local and export markets – know labeling requirements, packaging artwork review process, and regulatory annexes.
• Liaise with internal departments – develop a systematic approach for feedback loops with R&D, Production, Quality, and Marketing.
3. MATCH YOUR QUALIFICATIONS
• Academic – M.Pharm or B.Pharm from a reputable university.
• Experience – 1‑2 years in Global Regulatory Affairs or Formulation R&D is preferred; fresh graduates may apply if they demonstrate strong knowledge of regulatory submissions.
• Skills – planning and execution, quantitative & qualitative analysis, excellent written and verbal communication, ability to work shift‑based operations, and age ≤33 years.
4. TAILOR YOUR CV
• Highlight regulatory projects: specific CTD modules you prepared, markets targeted, and outcomes (e.g., approval dates).
• Emphasise any experience with eCTD software (e.g., eCTDmanager, Veeva Vault).
• List familiarity with international guidelines (ICH Q7‑Q12, ISO 9001).
• Include any cross‑functional liaison examples and shift work adaptability.
5. CRAFT A TARGETED COVER LETTER
• Open with a statement of interest in Square Pharma’s global growth, especially the Kenya expansion.
• Align your regulatory experience with the duties listed – give brief examples of dossier preparation, query handling, and artwork verification.
• Mention your commitment to the company’s health‑focused culture (non‑smoker stance).
• Conclude with confidence in meeting the November 30 2025 deadline and readiness for a virtual or onsite interview.
6. PREPARE FOR THE INTERVIEW
• Technical: be ready to discuss CTD module details, differences between CTD and ACTD, regulatory strategy for emerging markets, and a case study of handling a major authority query.
• Practical: prepare a mock CTD Module 3 (Quality) for a hypothetical product, including a summary of manufacturing process and control.
• Behavioral: examples of teamwork with R&D and Quality, handling shift schedules, and problem‑solving under tight timelines.
• Company‑specific: knowledge of Square Pharma’s recent product launches, certifications, and strategic goals in Africa.
7. APPLICATION PROCEDURE
• Submit the application through the provided eRecruitment link before the deadline.
• Attach a PDF version of your CV and cover letter only – hard copies are not accepted.
• Do NOT pay any fees; Square Pharma does not request money at any recruitment stage.
• Ensure your profile states that you are a non‑smoker, as smokers are discouraged from applying.
8. POST‑APPLICATION FOLLOW‑UP
• After submission, monitor the email address you provided for acknowledgment and possible interview invitations.
• Keep a copy of the job reference (Ref: HR/DU‑11‑25‑378) handy for any correspondence.
• Prepare a brief “thank you” note to send after an interview, reiterating your fit for the role.
End of preparation and technical guide.
